Pharmaceutical Project Risk

Identification
A Qualitative Study of Swedish Companies’

Pharmaceutical Project Risk Identification Process

Emma Nydén, Wilma Janzon Hägglund

Degree project, 30 credits, Spring 2022

Civilekonomprogrammet, International Business Programme 240 credits
Supervisor: Quang Evansluong
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 Abstract
The pharmaceutical industry has received increasing attention from society in recent years,
mainly due to the development of vaccines to counteract the spread of Covid-19. While other
industries have received sympathy for delays, inconveniences, and difficulties the pressure
towards the pharmaceutical industry to produce the vaccine against the virus has increased.
However, the Covid-19 pandemic has left no one untouched, it has affected the global
economy, increased the unemployment rate, reduced incomes, and resulted in disruption for
transportation. The Covid-19 pandemic has also left its mark in the pharmaceutical industry.
When lockdowns were implemented, it caused restrictions of in country and cross border
movements, hampering the transportation and delivery of pharmaceutical suppliers, causing
shortages or disruptions. This has resulted in an industry where unpredictability is constant,
while still aspiring to provide stability and safe products for the patients through their
projects. Even though the industry is known for working on projects, it is still immature in
comparison to other industries, regarding project management knowledge, and therefore also
knowledge about risk management. Generally, the pharmaceutical industry is hesitant
towards risk and being cautious can be beneficial when managing risk. However, the
pharmaceutical industry is dependent on innovation and development of new medicines
which is often associated with taking risks.

The purpose of this thesis is to provide insights into the beginning stages of risk management
for projects within the pharmaceutical industry, during the covid-19 pandemic in Sweden. The
Swedish pharmaceutical industry has during 2020 broken new records regarding exports and
increased the volume by ten percent whereas the general export in Sweden has decreased. This
study explores pharmaceutical projects’ risk identification by interviewing eight active project
members who have been a part of projects both before and during the Covid-19 pandemic.

A qualitative method was chosen for this study, paired with grounded theory that has provided
us with several implications for pharmaceutical projects and their risk identification. We have
discovered indications for the structure of the risk identification process. This structure
indicates four separate steps of the risk identification process. The first step is classifying risk,
where cross-functionality plays an important role. Afterwards, the risk identification process
enters the complex environment and continues to the second step. This step initiates the risk
search - mixed approach, consisting of the individual and collective approaches towards risk
search. Here, pharmaceutical projects can take guidance from stakeholders such as regulatory
authorities. The third step is reaction which can be altered by unpredictable disruptions or
governed by the stakeholders. In this case, the project re-assesses and returns to the second step
risk search - mixed approach. However, if the reaction is not to re-assess, the process continues
to the fourth step temporarily completed risk identification. Then, due to the long project
lifespans, the project will ultimately return to the first step and repeat the risk identification
process.

Our study contributes to new insights into pharmaceutical risk identification in several
theoretical ways. Mainly, we have shown that contrary to previous theories, the pharmaceutical
project risk identification entails the classifying of risks before the risk search. Additionally,
our findings generate insights for practical purposes for project members and relevant
stakeholders.

Keywords: Risk identification, Pharmaceutical industry, Covid-19 pandemic, Project

management
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 Acknowledgements

First and foremost, we would like to thank our supervisor Quang Evansloung from Umeå
University. He has provided guidance, feedback, and support throughout the process of writing
our degree project, which we are forever thankful for. Without his commitment, this degree
project would not been established.

Secondly, we would like to thank the co-students in our supervisor group, Moa, Olivia,
Sebastian and David for remarks and feedback during our process which has provided us with
helpful insights to enhance our degree project.

Lastly, we would like to thank all the respondents that have participated in our study for taking
time for the interview and trusted us with your wisdom that made this study possible.

May 23, 2022

Umeå School of Business and Economics
Umeå University

_________________________ _________________________

Wilma Janzon Hägglund Emma Nydén

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Table of contents

1. INTRODUCTION ............................................................................................................................................................... 1
1.1 PROBLEM BACKGROUND .................................................................................................................................................................... 1
1.2 ARRIVING AT THE RESEARCH PROBLEM ......................................................................................................................................... 2
1.3 RESEARCH QUESTION ......................................................................................................................................................................... 5
1.4 PURPOSE ............................................................................................................................................................................................... 5
1.5 FOCUS, DELIMITATION, AND LIMITATION ....................................................................................................................................... 5
2. SCIENTIFIC METHODOLOGY ....................................................................................................................................... 7
2.1 CHOICE OF SUBJECT ............................................................................................................................................................................ 7
2.2 PRE-UNDERSTANDINGS ..................................................................................................................................................................... 7
2.3 RESEARCH PHILOSOPHY..................................................................................................................................................................... 8
2.3.1. Ontology ................................................................................................................................................................................... 8
2.3.2. Epistemology ......................................................................................................................................................................... 9
2.3.3. Axiological............................................................................................................................................................................... 9
2. 4 RESEARCH APPROACH .....................................................................................................................................................................10
2.5 RESEARCH DESIGN ............................................................................................................................................................................11
2.6 LITERATURE SEARCH ........................................................................................................................................................................11
2.7 SOURCE CRITICISM ............................................................................................................................................................................12
2.8 OVERVIEW FOR CHOSEN SCIENTIFIC METHODOLOGY .................................................................................................................13
3.0 THEORETICAL FRAMEWORK ................................................................................................................................. 14
3.1 RISK IDENTIFICATION IN PHARMACEUTICAL PROJECT MANAGEMENT ....................................................................................14
3.1.1 Risk identification concept.............................................................................................................................................. 14
3.1.2 Projects in the pharmaceutical industry .................................................................................................................. 15
3.1.3 Pharmaceutical project management ....................................................................................................................... 16
3.1.4 Experience and risk identification ............................................................................................................................... 17
3.1.5 Risk and uncertainties within projects ...................................................................................................................... 18
3.1.6 Classifying pharmaceutical risks ................................................................................................................................. 20
3.1.7 Risk identification techniques in pharmaceutical projects............................................................................... 21
3.1.8 Concluding remarks ........................................................................................................................................................... 24
3.2 CONTEXTUAL INFLUENCES ON PHARMACEUTICAL PROJECT RISK IDENTIFICATION (PPRI) ..............................................24
3.2.1 PPRI and the Covid-19 pandemic ................................................................................................................................. 24
3.2.2 PPRI Sweden as a research context ............................................................................................................................ 26
3.2.3 Concluding remarks ........................................................................................................................................................... 27
4.0 PRACTICAL METHODOLOGY .................................................................................................................................. 28
4.1 DATA COLLECTION METHODS .........................................................................................................................................................28
4.1.1 Sampling technique ........................................................................................................................................................... 29
4.1.2 Conducting the interviews .............................................................................................................................................. 31
4.1.3 Interview guide .................................................................................................................................................................... 32
4.1.4 Recording and transcription .......................................................................................................................................... 34
4.2 DATA ANALYSIS .................................................................................................................................................................................35
4.3 RESEARCH ETHICS .............................................................................................................................................................................42
4.4 OVERVIEW OVER PRACTICAL METHODOLOGY .............................................................................................................................43
5.0 EMPIRICAL FINDINGS ............................................................................................................................................... 44
5.1 FINDINGS AND DATA STRUCTURE ..................................................................................................................................................44
5.2 AGGREGATE DIMENSION 1: CLASSIFYING RISKS THROUGH CROSS-FUNCTIONALITY ...........................................................45
5.3 AGGREGATE DIMENSION 2: SEARCHING FOR RISKS THROUGH VARIED APPROACHES .........................................................46
5.4 AGGREGATE DIMENSION 3: REACTING TO DISRUPTIONS AND COMPLEXITY ..........................................................................48
5.5 AGGREGATE DIMENSION 4: CONSIDERING EXTERNAL STAKEHOLDERS TO ACCOMMODATE DEMANDS ...........................50
6.0 DISCUSSION AND THEORY ELABORATION ....................................................................................................... 52
6.1 CLASSIFYING RISKS THROUGH CROSS-FUNCTIONALITY .............................................................................................................52
6.2. SEARCHING FOR RISKS THROUGH VARIED APPROACHES ..........................................................................................................52
6.3 REACTING TO DISRUPTIONS AND COMPLEXITY ...........................................................................................................................54
6.4 CONSIDERING EXTERNAL STAKEHOLDERS TO ACCOMMODATE DEMANDS .............................................................................55
6.5 PROCESS MODEL FOR RISK IDENTIFICATION DURING THE COVID-19 PANDEMIC IN PHARMACEUTICAL PROJECTS .......55
7.0 CONCLUSION AND CONTRIBUTIONS ................................................................................................................... 58
7.1 CONCLUSION ......................................................................................................................................................................................58
7.2 THEORETICAL CONTRIBUTIONS......................................................................................................................................................59
7.3 PRACTICAL RECOMMENDATIONS ...................................................................................................................................................60
7.4 SOCIETAL RECOMMENDATIONS ......................................................................................................................................................61
7.5 LIMITATIONS AND FUTURE RESEARCH .........................................................................................................................................62
8.0 QUALITY CRITERIA .................................................................................................................................................... 63
8.1 TRUSTWORTHINESS..........................................................................................................................................................................63
8.2 AUTHENTICITY ..................................................................................................................................................................................65
9.0 REFERENCE LIST ......................................................................................................................................................... 67
10. APPENDICES ................................................................................................................................................................. 73
APPENDIX 1. KEYWORDS SEARCH RESULTS ........................................................................................................................................73
APPENDIX 2. INFORMATION FORM - ENGLISH ....................................................................................................................................74
APPENDIX 3. INFORMATION FORM - SWEDISH ...................................................................................................................................77
APPENDIX 4. CONSENT FORM - ENGLISH.............................................................................................................................................80
APPENDIX 5. CONSENT FORM - SWEDISH............................................................................................................................................81
APPENDIX 6. INTERVIEW GUIDE - ENGLISH ........................................................................................................................................82
APPENDIX 7. INTERVIEW GUIDE - SWEDISH .......................................................................................................................................85
List of tables and figures

Table 1. Overview for chosen scientific methodology ............................................................ 13

Table 2. Risks involved in production projects management (Mohammad Sabbaghi and
Allahyari, 2020, p.112) ............................................................................................................ 21
Table 3: Themes in the interview guide ................................................................................... 33
Table 4: Overview of initial codes ........................................................................................... 36
Table 5: Overview of first-order codes .................................................................................... 37
Table 6: Overview of development of second-order codes ..................................................... 37
Table 7: Overview over development of aggregate dimensions .............................................. 40
Table 8: Ethical research principles ......................................................................................... 42
Table 9: Overview over practical methodology....................................................................... 43

Figure 1. Risk Event Graph (Larson & Gray, 2021, p. 215).................................................... 19

Figure 2: Overview of the data structure ................................................................................. 45
Figure 3: Process model for risk identification during the covid-19 pandemic in
pharmaceutical projects ........................................................................................................... 56
1. Introduction
The degree project will be initiated by an introduction of the problem background within risk
identification for Swedish pharmaceutical private firms during Covid-19. Subsequently, a
discussion of the arrival of the research problem will occur, followed by the research question.
Lastly, the purpose of the degree project will be displayed, accompanied by the focus,
delimitations, and limitations that the thesis will hold.

1.1 Problem background

The Covid-19 pandemic created a ripple effect in society and showed to be more than just a
healthcare crisis. It affected the global economy, increased the unemployment rate, reduced
incomes, and resulted in disruptions for transportation (Pak et al., 2020, p. 241). The
pharmaceutical industry took a blow in the initial phase of the Covid-19 pandemic. When
lockdowns were implemented, it caused restrictions of in country and cross border movements
(Tirivangani et al., 2021, p.1). This hampered the transportation and delivery of pharmaceutical
supplies, causing shortages or disruptions in the pharmaceutical supply chain. The idea of a
pandemic occurring has been speculated for quite some time (World Health Organisation,
2017). Additionally, with health crises such as the Ebola virus, the H1N1 and SARS pandemics,
and more universally, the 1918 Spanish flu, it could be argued that the world should have been
more prepared. Adversely, managers have the tendency to not provide the necessary attention
towards risk management (Cervone, 2006, p.256), which could be a result of the limited ability
organisational research has to explain how organisations do, and should deal with risk (Hardy
& Maguire, 2016). Limited research on risk identification, could be a reason why the world
was not responding to the risk of a pandemic occurring/happening.

As globalisation has increased over the past centuries and decades, the world has become more
interconnected, with supply chains spanning all over the world. This in turn, has made
companies more vulnerable to international events which could disturb parts of the supply
chain. This has become evident during the pandemic, and a prime example of this has been the
supply chain disturbances for pharmaceutical companies during the pandemic (Tirivangani et
al., 2021, p.1). Since China is the main exporter in the world, producing 60% of the world’s
API (Active Pharmaceutical Ingredients), the supply issues started early in the pandemic since
the virus had its first outbreak in China (Ozili & Arun, 2020, p.12). As previously alluded to,
the supply chain issues started at the beginning of the supply chain, making the issues grave
for many industries, including the pharmaceutical industry which could not order key
ingredients for their production in the quantities that they ultimately required (Tirivangani et
al., 2021, p.1).

A large portion of the research and development side of the pharmaceutical industry works in
projects (Hoon Kwak & Dixon, 2008, p.553). This creates a need for extensive risk
management and risk assessment. The pharmaceutical industry is somewhat less developed
when it comes to project management compared to other industries (Chauhan & Srivastava,
2014, p.57), and because of this, one can assume that pharmaceutical companies faced
impactful issues when they were forced to deal with unprecedented risk as a result of the
pandemic and its effects. The lack of research on risk assessment and more specifically, risk
identification, within the pharmaceutical industry poses a problem when these companies are
faced with an unavoidable risk in their environment. This, paired with the fact that project
managers often avoid counting in ‘scary’ or unknown risks, and instead focus on risks that they

1
have seen before or that are predictable to them and are also easy to handle. Many project
managers also avoid risks which they usually do not have to deal with since they are prone to
conduct a risk assessment largely because it is a requirement to get their projects approved
(Hoon Kwak & Dixon, 2008, p.553). This likely means that the current form of risk
management and risk identification which the pharmaceutical industry in Sweden uses today
is much less sophisticated or developed than it ought to be. If the risk management within a
company is effective and good at prohibiting harmful impacts from risks, this will create value
within projects, and ultimately for the company (Willumsen et al., 2019, p.731).

Existing literature tells us that in the world of private firms, risk is continually present (Hardy
et al, 2020; Hardy & Maquire, 2016; George, 2020). The phenomenon of risk generally has
negative connotations and companies are always working to identify and avoid risks (Hardy et
al., 2020, p.3). The inescapable presence of risk is something that companies have been forced
to realise, and the society we live in has, due to previous disastrous events, become a ‘risk
society’. Meaning that, since we cannot fully know what we do not know, we compensate by
engaging ourselves in debating, preventing, and managing risks that we, ourselves, have
created. Therefore, our society creates a vicious spiral (Beck, 2006, p.329) which can be
exemplified by the creation of chlorofluorocarbons (CFC). When CFC was developed, we had
no idea that 45 years later that we would realise that CFC caused destruction of the ozone layer.
Nobody could predict the unforeseen secondary effects of coolants could endanger mankind
through climate changes (Beck, 2006, p.330). The Covid-19 pandemic has been a contributing
factor to the ‘risk society’ that we live in, similarly to how previous disasters such as the Global
Financial Crisis have done the same, as described by Hardy and Maguire (2016, p.3).

1.2 Arriving at the research problem

Risk identification is important in today’s societal context, and specifically in companies that
work in unpredictable environments so that they can avoid risks to the largest extent possible
(Picciotto, 2019, p. 474). The existing research on risk identification contains several
techniques and tools for this process. Some of these include Risk Breakdown Structure (RBS),
Risk Profile, Fault Trees, Risk Event Graph, Brainstorming, and Checklists (Larson & Gray,
2021; Ahmed, Kayis & Amornsawadwatana, 2007; Rodrigues-da-Silva & Crispim, 2014).
What this existing research has in common is that it recommends people to work in groups
rather than individually when identifying risk. If more people are involved, this comprises the
knowledge of the project along with the specific context and environment of the project,
making it more possible to identify many of the important risks. Therefore, one should not
underestimate the power of the collective mind when it comes to risk identification.
Nevertheless, risk identification is the one technique that is mentioned and researched about
the least, in comparison to the other risk techniques (Elkington & Smallman, 2002, p.50) and
risks are impossible to avoid completely. The Project Management Body of Knowledge
produced by PMI suggests that all risks are identifiable. However, one of many human
limitations is that it is beyond our capacity to be able to predict all future outcomes due to a
lack of comprehension, suggesting that all risks actually are not identifiable, as supported by
Pender (2001, pp.81, 83). This may well have been the case with the Covid-19 pandemic. It
may have been beyond the scope of knowledge and ability of many project managers
throughout the world to predict.

Another limitation to the current praxis within project management is that risk is subjective. A
risk may be valued in a certain way according to one person, and it can be valued quite
differently according to someone else (Campbell, 2006, p.227). Therefore, identifying risky

2
projects might not be as easy as it seems. Risk assessment is the process where companies
identify and judge the likelihood of events with negative impact occurring, and the subsequent
impact that this may entail (Williams, 1996, p.185). Catastrophic consequences can come from
the failure to manage risks adequately, and therefore it is crucial to conduct risk identification
within risk assessments for companies who are trying to survive in the uncertain world we live
in. The risk identification process is the first step in the risk assessment. It is thereby the catalyst
for being able to carry out risk management (Elkington & Smallman, 2002, p.50), constituting
a crucial tool for organisations. Today, we commit ourselves and try to control risks by always
identifying and managing risks in our society (Hardy & Maguire, 2016, p.3). Due to the
subjectivity of risk and individual valuations of risk, we deduce that it is difficult to use one
mainstream approach to risk assessment, and more specifically risk identification. Therefore,
there is a need to create a better way to identify risk to make the risk assessment process more
effective and to counteract the consequences of the ‘risk society’.

Projects and their teams are constantly needing to identify risks in their environment, both
internally and externally (Hardy & Maguire, 2016, p.21). One of the most referenced pieces of
literature when it comes to project risk identification is Chapman and Ward (2003). Existing
literature emphasises the importance of risk being identified at the earliest stage possible within
projects (Chapman & Ward, 2003, p. 105). There is also emphasis on bringing in several people
to consult throughout the risk identification process, such as customers or other stakeholders
along with the people working within the project and the project manager (Chapman & Ward,
2003, p. 106). Three out of five tasks in the identifying phase of project risk management
include summoning people for help with identifying risks. These people are associated with
different parts and stages of the project, and so they help with creating a holistic image of
project risk (Chapman & Ward, 2003, p. 106). However, project managers might not give risks
the attention it needs, some even conduct risk management during the planning phase, in order
to meet the requirements of getting the project approved (Hoon Kwak & Dixon, 2008, p.553).
According to Cervone, this does not consequently imply that project managers do not consider
the issues attached to risks (2006, p. 256). Instead, project managers conduct a comprehensive
survey of the project and its risks to know how much "margin of risk" they should add on
(Cervone, 2006, p.256). Hence, project managers do not completely ignore risk, but they only
carry out very superficial practices to prevent the risks from taking place and therefore, spotting
real risky projects can be hampered due to the generalisation from project managers. As a result
of lack of awareness and over-optimism about one's project, leading to project managers not
accepting the part of reality which states that projects are risky undertakings (Raz et al., 2002,
p. 107).

Instead of exploring and mapping out possible unknown risks, project managers tend to focus
only on the most common risks they have observed in the past (Hoon Kwak & Dixon, 2008,
p.553). Today, having a good project plan with an evolved monitor- and control system is not
enough. Many projects experience delays, overruns, and defeat even though risk management
tools and techniques have been developed to counteract these outcomes. However, not many
project managers use the tools and techniques to gain project success (Raz et al., 2002, p.101).
Project risk management practice has shown to be correlated with the success of meeting the
project's time and budget goals (Raz et al., 2002, p.105). Additionally, a clear indication for
the need of continuous research on project management to provide practitioners with
instructions and tactics for their project management approach is the rapid increase in
memberships with the Project Management’s Institute (PMI) (Larson & Gray, 2021, p.5).
Therefore, by developing a set of indicators or identifiable conditions so that risks with a project
can be detected and addressed before the project has failed will be favourable for projects and

3
companies that carry them out (Pinto & Mantel, 1990, p. 268). Project risk management should
be implemented into the culture of project management activity as a routine and recurring
event.

There is a clear bias in project management when it comes to which projects get more attention
paid towards risk management. Project risk management practices are added to a higher extent
towards projects that have greater uncertainties to prevent the risks, because of the
preconceived notion that exists, that high-risk projects are often less successful than low-risk
projects (Raz et al., 2002, p.105). Often, even managers who have more experience are also
appointed to more complex projects while less experienced get simpler types of projects (Raz
et al., 2002, p.102). In fact, high-risk projects are no less successful than low-risk projects (Raz
et al., 2002, p.105). Managers do not put as much focus into preventing risks or using risk
management techniques or tools in low-risk projects. While in high-risk projects, more
techniques are resorted to, and the projects are managed more carefully and therefore the two
types of projects have the same level of success. Something that is missing and needs to be
made visible is that projects with low uncertainty can also face delays and do not have success
as a guarantee. Although high-risk projects have greater uncertainties and may require greater
resources, low-risk projects should also use risk management practises to minimise the risk of
failure and increase the success rate. However, in the same way that there are different types
of projects, different types of risk management practices are also needed, which can be used in
different ways and for different purposes. Nevertheless, the message remains, high-risk
projects should not be the only projects to engage in project risk management. Projects with
lower risk, and therefore projects in general, would benefit from enforcing project risk
management (Raz et al., 2002 p.107).

As mentioned, pharmaceutical companies tend to work in projects and projects contain risks.
Through previous studies, it has been shown that pharmaceutical project management is less
mature than in other industries such as financial services, telecoms, and engineering
construction (Chauhan & Srivastava, 2014, p.57; Cooke-Davies & Arzymanow, 2003, pp.475,
477). Even when compared to other high-tech industries such as IT, Aerospace and
manufacturing, the pharmaceutical industry is still a bit behind (Chauhan & Srivastava, 2014).
The reason why this is so may be many, but for pharmaceutical companies, implementing an
effective risk management in projects is both challenging and demanding (Hoon Kwak &
Dixon, 2008, p.552). Additionally, from a broader and more in-depth perspective, more
research has been done in the field of IT than pharmaceutical (Hoon Kwak & Dixon, 2008,
p.554), which can further explain their lack of risk management in projects. Having said that,
the lack of implementation causes a higher chance of risk appearing which has proven to
implicate in exceeding budget and postpone schedule. Therefore, providing a way to implement
an effective risk management for pharmaceutical companies can contribute projects to
encounter cost, schedule, and specification (Hoon Kwak & Dixon, 2008, p.553), and
additionally, prevent excessive firefighting.

The Swedish pharmaceutical industry broke new records in exports, increasing the volume by
ten percent, while Sweden's exports in general decreased with six percent during 2020 (lif,
2022). We consider Sweden to be highly engaged within the pharmaceutical industry, since
one of the leading pharmaceutical companies in the world, AstraZeneca originates from
Sweden, along with other companies such as AkzoNobel, Vitrum and Nouryon.

4
1.3 Research question
In reference to previously mentioned research gaps and the background to the topic, the
research question we aim to answer with this degree project is:

- How do companies conduct risk identification within pharmaceutical projects during

the covid-19 pandemic in Sweden?

1.4 Purpose
The purpose of this thesis is to provide insights into the beginning stages of risk management
for projects during Covid-19 in Sweden, within the pharmaceutical industry, which is of crucial
importance to our society. Therefore, the goal is to establish an insight and gain a deeper
understanding around pharmaceutical companies approach when identifying risk in their
projects, during the covid-19 pandemic in Sweden. Although previous literature concerning
risk management and the role it has within a project is well-documented, we strive to broaden
the knowledge through our degree project by including practitioners using interviews. In
addition, we aim to elaborate how pharmaceutical companies have managed identifying risks
during the pandemic, where uncertainty is consistent. By exploring which strategies and
practices are successfully useful for pharmaceutical companies, we desire to bring value for
future research and practitioners when identifying risk and proceeding with projects. In
addition, in our judgement, the study could introduce techniques and generate knowledge for
future disasters, potentially resulting in rapidly and more efficient prevention and protection
towards disasters. However, on the one hand, disasters are highly unpredictable in both effect
and occurrence. Therefore, it can be complicated to predict what is to come for the future. One
the other hand, we argue that our study can still provide an understanding and insight into how
companies can make themselves more prepared for uncertainties. Which is useful and
beneficial for companies involved in projects but also for more general companies in uncertain
environments. It could potentially guide and support them in elections and decisions regarding
similar environments.

1.5 Focus, delimitation, and limitation

The focus of our degree project will be on analysing pharmaceutical companies exclusively.
The selection was made based on the desire to capture an industry that evolves, to a high degree,
around projects and as previous studies have shown (Chauhan & Srivastava, 2014, p.57) is less
mature in project management. We are aware that, deciding on the pharmaceutical projects’
perception and their evolution regarding risk, we turn our backs on many industries and
perspectives that manage risk e.g., financial services and engineering construction.
Nevertheless, these fields could be an enchanting area to study for future research. Even though
we will not focus on these fields, it is possible that the contributions our degree project will
generate could be applicable to other industries as well, that stands in front of similar
uncertainties and unpredictable environments. However, as mentioned, the study will solely
focus on the pharmaceutical industry, as we sought to concentrate on the detected research gap
within pharmaceutical project management.

We have also delimited our thesis to analyse a specific part of risk assessment, risk
identification. This is because we want to gain a detailed understanding about how
pharmaceutical companies approach risk, and how they work to identify these risks in their
5
environment. If we were to analyse risk assessment, we believe that this would be too broad,
and that this could leave our results quite scattered, losing the potential to answer a specific
and detailed research question. That is the reason for our specificity within risk management
and risk assessment. We have also chosen risk identification since we believe that there is a
gap in the current research, specifically when it comes to risk identification within specific
industries such as the pharmaceutical industry. There are many articles and authors which
investigate the risk assessment process and where risk identification is mentioned as a step
along the way (Williams, 2017; Project Management Institute, 2021), but there is often no in-
depth analysis into the specific identification process. We hope to contribute to filling this gap,
and to provide some answers which hopefully can be extrapolated into other industries outside
of our chosen industry.

Additionally, we will limit this study to pharmaceutical projects in a certain geographical area,
which we have chosen to be Sweden. This enables us to have as many common factors between
the participants as possible to be able to analyse their answers based on their common
background. Furthermore, something that reinforces our choice of limitation was the covid-19
pandemic. Regulations, restrictions, and precautions that have been implemented by different
governments within their countries due to the pandemic have caused companies to experience
different environments even though they exist on the same market. Since the preventive
measures have been severely different between countries, focusing on one country enhances
the possibility to compare the participants in an unbiased way. Therefore, the ongoing covid-
19 pandemic has played a part in the geographical limitation.

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2. Scientific methodology
For this chapter, we start to discuss the choice of subject and pre-understandings. Thereafter,
we have mentioned research philosophy and addressed our philosophical assumptions.
Subsequently, the research approach and research design are discussed to give more insight
into why our degree projects are shaped as it is. Lastly, literature search and source criticism
are presented.

2.1 Choice of subject

The choice of research subject originates from a project management course within
Civilekonomprogrammet at Umeå University. During the course, our interest in risk
management within projects emerged which eventually forged this research subject.
Subsequently, we began to search for research gaps and niches within project management.
Our first direction was to explore companies' entire risk management process which, due to
lack of time and resources, was adjusted. With the support from our supervisor, we narrowed
the area down to project risk identification. Secondly, we thought about looking into the
construction industry, since they frequently conduct projects. However, we identified that the
pharmaceutical industry was not as researched or covered as the construction industry, and
thereby we could justify the need for further research to be conducted. The pharmaceutical
industry became more suitable since it also became apparent that the industry had been highly
affected by the ongoing covid-19 pandemic. In addition, the covid-19 pandemic has displayed
new challenges for companies from the perspective of business research. Altogether, we have
found risk identification for pharmaceutical companies, affected by the covid-19 pandemic to
be a suitable object for this study.

2.2 Pre-understandings
Preunderstanding is previously retrieved knowledge, insights and experience which becomes
useful when comprehending “new” research and contexts (Ryan, 2011, p.220). Additionally,
pre-understanding can enhance the quality of a research, since it can increase both visibility
and transparency, as well as proximity to the phenomenon (Stenbacka, 2001, p.554). Our
preunderstandings related to our topic mainly lie within project management and risk
management. As mentioned above, we have taken courses related to project management
before, and we also have seven semesters of experience in university courses within business
administration. However, our preunderstandings about the topics related to this thesis are
mostly second-hand preunderstandings. This means that they are based on literature rather than
first-hand experiences (Stenbacka, 2001, p.554). This means that proximity to the phenomenon
may be more of a challenge in our case compared to if we were to have first-hand
preunderstandings. We will remain aware of them throughout our research process and make
every attempt to ensure access through proximity and understanding of the phenomenon we
are researching (Stenbacka, 2001, p.553).

Furthermore, our knowledge about the pharmaceutical industry is limited. This is especially
true about the industry before the covid-19 pandemic. This can display itself as a barrier
(Stenbacka, 2001, p. 553) since we will not have any first-hand pre-understandings concerning
the pharmaceutical industry. First-hand pre-understanding is acquired through personal
experience, whereas second-hand is based on literature (Stenbacka, 2001, p.553; Ryan 2011,
p.220). However, through previous knowledge within management, specifically regarding risk-
and project management, we will attempt to conquer the barrier, combined with an objective

7
literature research. An objective literature research is conducted to prevent possible partiality,
and to move towards a holistic view on the phenomenon (Stenbacka, 2001, p.553). Previous
experiences laying the base for biases and partiality should be mitigated by the process of an
objective literature search.

2.3 Research philosophy

Research philosophy is derived from the research paradigm. There are two main paradigms,
positivism and interpretivism (Collis & Hussey, 2014, p.43-44). Research philosophy presents
the fundamental assumption during the research, since it is the nature of knowledge, reality,
and existence (Collis & Hussey, 2014, p.43). Therefore, it is essential for researchers within
management to contemplate this since the different philosophical choices can determine and
impact the study extensively. Interpretivism is the paradigm most often used when conducting
research within the social and humanitarian sciences. This is because interpretivism allows for
the subjectivity of reality, along with the existence of multiple individually experienced
realities (Collis & Hussey, 2014, p.46). Interpretivism is often used for research within
humanist areas as it pairs well with the qualitative method (Collis & Hussey, 2014, p.46). The
qualitative method and the interpretivist view allow for research to gain a deeper understanding
about a phenomenon or subject, also being our goal with this thesis. This can be done through
interviews where the respondent reflects on their own experiences and their subjective reality
along with their personal relationship to and experiences with the phenomenon (Bell et al, 2019,
p.32). We want to gain a deeper understanding about the risk identification process within
Swedish pharmaceutical projects before and during the Covid-19 pandemic. On the contrary,
positivism takes an objectivist approach, where reality exists separately from social actors
while also being objective and observable, and often ‘measured’ by testing hypotheses (Bell,
Bryman, and Harley, 2019). The positivist approach works towards generalising a result for
the relevant population along with extrapolating the results into predictions (Collis & Hussey,
2014, p.46-47), while this is not seen as the purpose when the interpretivist approach is used.

There are three main assumptions in the research philosophy; ontology, epistemology, and
axiology (Collis & Hussey, 2014, p.47-48; Saunders, 2019, p.133), which will be presented
below. Initially, we will clarify the choice within philosophical assumptions made for our
study. Then, we will also explain what the choices will mean for the study and finish with
presenting the arguments to justify why these choices were made and why other philosophies
were not applicable in our context.

2.3.1. Ontology

We have chosen subjectivism as our ontological view for this thesis. This is because it aligns
with our research area which belongs in the social sciences. Ontology is the philosophical
assumption regarding the nature of reality, and we have chosen to approach ontology from the
interpretivist end of the continuum of paradigms, resulting in subjectivism (Collis & Hussey,
2014, p.49). This end of the paradigm operates from the assumption that reality is a social
construct produced as a result of human interaction and imagination, and there are multiple
realities (Collis & Hussey, 2014, p.49). Therefore, we deem this appropriate for our thesis,
since we will be interacting with our respondents to gain an understanding about their
subjective realities and contexts (Helmi Alharahsheh & Pius, 2020, p.41-42). The most
prevalent constructs relating to our thesis are risk identification and project management, which
both are built on human interaction and can be argued to be social constructs, further
strengthening the argument for the subjectivist approach.

8
Objectivism is on the other end of the continuum of paradigms. This assumption falls under
positivism, which views reality as something external to the researcher that can be observed
and then measured (Collis & Hussey, 2014, p.49). Because of this, it is often used in the natural
sciences, where knowledge is more absolute and quantifiable (Saunders et al, 2019, p.133).
Objectivism is not suitable for our study since we want to gain a deeper understanding about
our respondents’ own realities and experiences, implying that we need to acknowledge the
existence of several realities (Helmi Alharahsheh & Pius, 2020, p.42). Subjective reality is not
something which can be ‘observed’ in the sense that objectivism suggests, but we as researchers
need to be a part of the study to be able to interpret the respondents’ experiences, something
which can only be done by the use of subjectivism. Other than the nature of reality, the view
on knowledge and its validity also needs to be considered for this thesis. Epistemology is the
philosophical assumption concerned with knowledge, and what we deem to be valid knowledge
(Saunders et al, 2019, p.135).

2.3.2. Epistemology

Epistemology pertains to what we see as acceptable and valid knowledge. This differs greatly
between interpretivism and positivism (Saunders et al, 2009, p.119). Epistemology also
concerns how a researcher goes about revealing and uncovering knowledge (Helmi
Alharahsheh & Pius, 2020, p.40). Under interpretivism, complex and individual views on
reality and the prevalence of different contexts constitutes acceptable knowledge. It is even
preferred, as the researcher wants to gain a deeper level of understanding about the topic of
relevance (Saunders et al, 2009, p.116). The most appropriate approach to this study will be
the interpretivist view. We argue that this is the case because we want to find out about our
respondents’ feelings and experiences to gain an understanding about their experience with risk
identification in pharmaceutical projects before, and during the pandemic. This means that we
constitute our respondents’ individual and contextual experiences and realities as valid
knowledge in this study.

Positivists see tangible and objective facts as the most accepted knowledge, and often conduct
research in the social sciences through the use of a deductive method and surveys, similar to
research in the natural sciences (Bell et al, 2019, p.30). This is done in an attempt to ‘measure’
the phenomenon they are researching. Interpretivists argue that social interactions and the
knowledge collected from an interpretivist approach are not quantifiable, but instead should be
analysed more in-depth within its context to gain a deeper understanding with the use of an
inductive approach (Bell et al, 2019, p.31). One important criticism towards interpretivism is
how the subjective values and biases of the researcher(s) affects the research being conducted
(Collis & Hussey, 2014, p.48)

2.3.3. Axiological

The axiological assumption pertains to how one’s values affect the research being conducted,
and how this should be addressed appropriately according to the chosen philosophical
assumption (Collis & Hussey, 2014, p.47). Positivists often criticise the interpretivist view
because they argue that research should be conducted free of values on behalf of the researcher
(Saunders et al, 2009, p.114). This approach is not appropriate for our study because we argue
that to answer our research question in a satisfactory manner, we must allow our values to
influence our research. This decision is supported by the interpretivist assumption that humans
and their knowledge are inseparable (Helmi Alharahsheh & Pius, 2020, p.42). This is likely to
present itself in the theories we chose to include, the questions we ask in the interviews, and
the analysis we perform on the collected data. We are aware that our values will influence the
9
study, but we also argue that it is necessary to fulfil the purpose of the study and for us to gain
an understanding about risk identification in pharmaceutical projects.

Another reason for why the positivist assumption is inappropriate for this study is that we
cannot guarantee that the research will be free from bias and values. Even if we are aware of
some of the ways in which our values affect our study, we are surely not aware of all the ways
our values and biases affect our research. Furthermore, to make sure that our choices are
compatible and work together, choosing philosophical assumptions on the same side of the
continuum of paradigms is important for a coherent scientific method. This means that we
should make choices which reflect the situation we are in with our study and make choices
which allow us to approach the research from a subjective point of view.

2. 4 Research approach
The thesis aims to answer the research question through an inductive process. This begins with
empirical observation, and thereafter we will attempt to detect a pattern within the relevant area
of research. This approach aligns with our purpose of the thesis, aiming to make generalisations
to a broader area. In sociology, there are two primary methods to conduct a study, deductive
and inductive (Collis & Hussey, 2014, p.7). These two approaches are complete opposites of
each other, describing the most extreme parts of the spectrum, beginning their reasoning logic
from each end of the spectrum. However, it has become more acknowledged that a combined
approach is used, both deductive and inductive processes during the study, an abductive
approach.

The inductive approach was developed when deductive became deficient, which is when
deduction cannot describe or clarify human interaction in a social perspective (Saunders et al.,
2019, p. 155). The lack of capturing social science with the deductive approach has created a
demand for the inductive approach. Since interviews will demand social interaction, our
judgement is that the inductive approach is more suitable for our thesis. The inductive approach
is a method where the reasoning starts by observing empirical reality, subsequently followed
by a generalisation. Therefore, the inductive approach can be described as moving from the
specific to the general (Collis & Hussey, 2014 p. 7). As mentioned, the inductive approach is
more appropriate for our study, since the purpose of this thesis is to provide insights into the
beginning stages of risk management for projects during Covid-19 in Sweden, within the
pharmaceutical industry, which is of crucial importance to our society. Thus, hopefully be able
to generalise the findings, going from experience to theory, and applying the theory to other
industries or areas. Since the deductive approach is contradictory to the inductive, the deductive
becomes inapplicable.

The deductive approach has a theory as the basis of empirical study and is the way natural
science normally conducts their studies, since it captures the data in a better way (Saunders et
al., 2019 p. 153-154). With deduction, the theoretical frameworks that have been developed
are tested against the empirical findings (Collis & Hussey, 2014 p. 7). Initially stating
hypotheses which creates the foundation for the study and then either reject or accept the
hypotheses, depending on the empirical findings. With our study, we detect some difficulties
in quantifying the data in the deductive approach, risking leaving out important parts of the
research due to the lack of knowledge discrimination in social science. Hypothesis testing is
not preferable in our study and consequently neither is deductive or abductive approach.
Additionally, according to Collis and Hussey (2014, p.47) the inductive is the most suitable

10
approach when conducting a study with the previously mentioned interpretivism assumptions
we have.

2.5 Research design

Since we aim to deepen the understanding around pharmaceutical companies' ability to identify
risk in their projects the chosen research classification for this thesis will be analytical research.
The chosen research design relates to the purpose of the study and then indirectly connects to
the research question we aim to answer (Saunders et al. 2019, p. 173). Our study aspires to
answer the question of ‘how’ the analytical research, also known as the explanatory research,
connects the parts properly. This research goes further than describing characteristics, to
analysing and explaining the phenomena that are being studied (Collis & Hussey, 2014, p.5).
This aligns well with our chosen research question, since we want to find out how Swedish
pharmaceutical companies conduct risk identification in project management during the Covid-
19 pandemic.

Exploratory, descriptive, and predictive research are other methods that could be used. An
exploratory research method is well suited for a phenomenon that has only a few or no earlier
studies (Collis & Hussey, 2014, p.4), to generate a basic idea of the phenomenon. Since the
field we aim to study has an established foundation and a great amount of existing literature,
we consider this method not as suitable as analytical research. Furthermore, the descriptive
approach could have been appropriate if we had another take on our topic. The descriptive
approach aims to describe the phenomena as they exist (Collis & Hussey, 2014, p.4), which in
our context, will not provide as much depth as the analytical research will, as this omits the
‘how’, which is crucial to our research. Lastly, predictive research, which goes even further
than every earlier mentioned research. Predictive research goes even further than the analytical
by developing and explaining future prediction, based on hypothesised and general
relationships (Collis & Hussey, 2014, p.5). This could be useful in the future. However, the
Covid-19 pandemic has caused a unique environment, making it difficult to generalise it to a
prediction, which is supposed to be applicable elsewhere in the future. Conclusively, exploring
the additional methods further demonstrate that the most suitable design to select for our study
is the analytical design.

2.6 Literature search

The process of the literature search for a thesis project is crucial to the success of the project.
This is because literature search and reviews allow the researcher to identify and understand
the existing body of knowledge of the topic under investigation, which in turn reveals the
relevant research gaps (Xiao & Watson, 2017, p.93). It is important to search for literature with
the relevant context in mind (Bell et al. 2019, p.95). Presenting the literature search and review
is also a conscious effort on behalf of the authors to provide high methodological transparency,
as suggested by Aguinis et al (2018, p.86).

Within our literature search process, we have used a ‘funnel’ approach, as suggested by Xiao
and Watson (2017, p.103). This has meant that initially, we searched for keywords relating to
our research question and risk identification. These keywords, along with the number of search
results in Google scholar can be seen in Appendix 1. Early on we discovered that risk
identification was connected to comparable keywords and included in larger contexts such as
‘Riskification’, ‘Risk Assessment’ and ‘Risk management’. Subsequently, we used the
additional keywords in the literature search to retrieve greater knowledge of the subject. The

11
search highlighted the pharmaceutical industry as lacking in literature of risk identification and
general risk management. This resulted in narrowing the search to address risk identification
specifically for the pharmaceutical industry and pharmaceutical projects. Thereafter we read
articles and books about our chosen topic to gain an understanding about the current body of
knowledge and decided if the research gaps are significant enough to justify our research. When
looking for existing research, one needs to have a screening technique for what literature should
be referred to within the thesis. We firstly inserted our key words into the search function used,
which mainly was Google Scholar. Then we looked at the titles of articles, books, and book
chapters to see if it related to our area of research. After this, we made sure that the abstract
was relevant, and that it contained the information we were looking for. Finally, we made sure
that the full text also pertained to our chosen area and that the information included was relevant
(Xiao and Watson, 2017, p.103). In our case, there were some articles we found which could
be eliminated due to their irrelevance to our topic. These articles were for example, related to
later stages in risk management.

Other than the information provided in the literature under review, researchers also need to
ensure the credibility and quality of the literature. There are many different opinions on how
the inclusion and exclusion criteria should look like when it comes to quality of literature.
However, ultimately, it is up to the authors to agree on how they want to design the inclusion
and exclusion criteria. One way to rank and judge the quality of studies and other literature is
with checklists (Xiao and Watson, 2017, p.106). We have decided to include literature which
fall under the following list of criteria: (1) articles should be peer reviewed and available in
full-text, (2) published by an academic journal and (3) Books should either be recommended
by lecturers as course literature or frequently referred to in peer-reviewed literary works. In
addition, to evaluate the quality of our literature used in our theoretical framework we used the
Academic Journal Guide 2021 (It was earlier ABS 2021) Ranking list (Kumar Jena, 2021).
According to the ranking list, a significant amount of our literature claimed a 4-ranking and 3-
ranking which indicates that the retrieved articles originate from Journals of higher quality.
The databases mainly used during the literature process of this thesis were Google Scholar and
the Umeå University library database. According to Bell et al. (2019, p.98), online databases
are the most valuable sources of academic journal references. Furthermore, as mentioned
previously, course literature from past courses were also used.

2.7 Source criticism

When gathering information from existing literature, it is important to critically review the
sources. As mentioned, we have mainly used Google Scholar and the Umeå University library
database as our sources when gathering information from previous research. Despite these two
sources having a large amount of information and existing literature, it is important to remain
critical towards sources before deciding to use them. There are four different criteria which lay
the foundation for source criticism according to Thurén and Werner (2019, p.12)., which are
authenticity, time context, interdependence, and the freedom of tendency.

Authenticity concerns the legitimacy of the source when it comes to distinguishing between
real and fake information. A source is authentic if it lives up to what it claims to be and is not
falsified in any way (Thurén & Werner, 2019, p.27). One way of analysing authenticity during
this thesis has been to cross-check with other sources to see if they portray a similar sentiment.
If two sources make opposing claims regarding the same topic, then further analysis will be
needed to make sure that correct information is included in the thesis. Controlling a source for

12
authenticity is especially important when it comes to using the internet (Thurén & Strachal,
2011, p.13).

Time context is the second criteria. This criterion addresses the relation between the time of the
event and the story of it. If longer time has passed since the story was written, you have more
reasons to doubt the story (Thurén & Werner, 2019, p.12). The more in time an article is
written, the more reliable the source is (Thurén & Strachal, 2011, p.14). During our study, the
used sources have a breadth regarding the years they are published. This may cause them to be
less reliable than recently published articles. However, we have aimed to always use the latest
published articles to apply as updated knowledge as possible. Older articles have been applied
in combination with other additional and more current articles, to ensure that the older articles
are still relevant. The reason why we have used older articles is mainly because risks within
projects began to receive attention at the same time as project management started to grow,
during World War II, with the Manhattan-project (Larson & Gray, 2021, p.20). This created
the foundation and definition of risk. However, it has stayed undeveloped until recently when
project managers have realised the impact of bad risk management (Larson & Gray, 2021, p.
213). Therefore, older articles have contributed to the foundation while more up-to-date articles
have increased the knowledge and made it more applicable to modern days.

The third criteria are concerning interdependence. Interdependency implies to ensure that the
source is not just a transcript or summary of previously published sources (Thurén & Werner,
2019, p.12). Throughout our degree project, we have constantly used primary sources to create
our foundation used in literature research. When discovering an intriguing theory or model we
aspired to seek the primary source, instead of using any secondary references. This is also a
factor to why we have used older published sources, as previously mentioned. Lastly, the
criteria freedom of tendency, intend to ensure that authors of sources have not had any ulterior
motives and therefore provided an incorrect image of reality (Thurén & Werner, 2019, p.12).
To take this criterion into consideration we have used peer-reviewed sources or books in
combination with peer-reviewed sources to strengthen the impartiality and quality of our
degree project. However, there is a challenge in ensuring that the authors of the used sources
are completely impartial, which is a consideration to take into account.

2.8 Overview for chosen scientific methodology

Table 1. Overview for chosen scientific methodology

Philosophical assumptions
1. Subjectivism
1. Ontology 2. Interpretivist
2. Epistemology 3. Interpretivist
3. Axiological

Research approach Inductive approach

Research design Analytical

Literature research Funnel approach

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3.0 Theoretical framework
Our theoretical framework establishes a comprehensive synthesis of relevant literature
integrating studies on (1) risk identification (2) pharmaceutical project management, and (3)
contextualised for the Covid-19 pandemic and Sweden as the geographical location. We
critically examine the existing literature by unpacking the central key concepts and highlight
the relevant gaps related to the three above mentioned topical areas. The chapter is structured
in a way so that different topical areas have been integrated, forming a theoretical framework
which is appropriate for the purpose of our thesis. We have connected risk identification with
pharmaceutical project management to give a better understanding of how they work together
and explore what the relevant knowledge gaps in the existing literature are, along with their
importance. Furthermore, we have looked at how risk identification within pharmaceutical
projects may be affected by the geographical location and the Covid-19 pandemic in order to
pay attention to the context of the thesis and its purpose, and to give more depth to our
theoretical frame of reference.

3.1 Risk identification in pharmaceutical project management

The following section will cover the subject matter regarding risk identification and
pharmaceutical project management in a combined way. The section is structured to (1) give
the reader an understanding of risk identification as a concept before (2) incorporating
pharmaceutical project management, to finally (3) demonstrate how risk identification should
be searched for and classified based on existing literature in pharmaceutical projects.

3.1.1 Risk identification concept

When a company, project or temporary organisation implements risk management there are
several steps to complete, including risk identification. For companies, risk management's main
obligation is to estimate the risk for the company and then communicate it to top management
(Sultz, 2008, p. 40). According to George “whether major or minor, all risks should be isolated
and treated accordingly” (2020, p.975). The top management’s responsibility is to determine,
based on their risk appetite or tolerance, how to manage the risk. Whereas for projects, risk
management's main responsibility is to work as a preventive process to reduce surprises and
negative consequences caused by unwanted events (Larson & Gray, 2021, p.215). Risk
management can therefore be defined differently depending on its purpose. To ensure that the
pharmaceutical project meets its objective, it is therefore important that the risk management
is processed correctly and aims to avoid and minimise uncertainty (Brown & Grundy, 2016, p.
123).

Risk identification consists of two tasks: (1) searching for risks and (2) classifying the risks
(Chapman & Ward, 2003, p.105). Since risk identification is the first step in the risk
management process, it is the initiative component that paves the way for the rest of the risk
management process. In agreement with Brown & Grundy (2016, p.128) only a foolish project
manager would manage a project, believing that no risks will emerge. As described, an ignored
risk at the beginning, can appear later on during the project, impacting the project at a much
higher cost than if the risk would have been managed earlier. Emphasising the importance of a
well conducted identification of risks and the benefit of a proactive approach. Having said that,
the difficulty with risks is that it has a way of repeatedly appearing during the project life cycle.
When previous risks have been addressed, new ones come up (George, 2020, p.975). A
common mistake done during the risk identification is to only focus on objectives and not the

14
event that could cause consequences (Larson & Gray, 2021, p. 217). For example, seeing the
objective risk of failing to meet the budget, while actually the event causing it might be
excessive spending, poor negotiating towards suppliers, or poor estimates. By also searching
for the event causing the risk, one could find the solution to prevent the risk completely (Larson
& Gray, 2021, p.217).

Risk can be defined very differently on a case-by-case basis (Chapman & Ward, 2003, p. 7).
According to the US Project Management Institute (PMI) risk is “an uncertain event or
condition that, if it occurs, has a positive or negative effect on a project objective” (2000, p.
127). If the uncertain events appear, it will affect the project objectives, meaning the cost,
schedule, and quality (Larson & Gray, 2021, p. 213). The UK Association for Project
Management (APM) has a similar definition, saying that risk is “an uncertain event or set of
circumstances that, should it occur, will have an effect on the achievement of the project’s
objectives” (1997, p. 16). What the definitions have in common is that they both emphasise the
two components of risk; likelihood to occur and impact. Risk comes natural in projects, no
degree of planning could conquer risk (Larson & Gray, 2021, p.213), therefore in the
environment's projects provide, risk is an uncertain event. Risk has a cause and, if it
materialises, an effect (Larson & Gray, 2021, p.213). When conflicts about risk arise between
the public and the experts, it can often be traced back to the unestablished disagreements about
the topic, including what is meant by "risk” (Fischhoff et al., 1984, p. 124). Additionally, when
the concept of risk is not defined, decision-makers rely on their own assumptions about the
meaning of risks (Yildiz, Dikmen and Birgonul, 2014, p.522). Without a clarification of risk,
miscommunication and confusion are more likely to appear.

The theories generated from research with decision-makers involved does not always
accurately represent what reality looks like. In the research being conducted on decision-
making within risk management, the decision-maker is often given well-defined problems and
the probability distribution connected to the situations, on which they can base their decisions
(Maytorena et al., 2007, p.317). However, to actually make the right decision, the decision-
makers need to actively search for information which they might not initially have (Maytorena
et al., 2007, p.317).

Risk is present in all types of work, and risk management is very prevalent in project
management literature. The risk management process is key to the survival of projects, and
often occurs in the beginning of the project life cycle, as this is the point in time when risks
have the lowest cost to the project (Larson & Gray, 2021, p.214). However, both the project
lifecycle and the risk management process differ between industries, and the pharmaceutical
industry and projects are no exception.

3.1.2 Projects in the pharmaceutical industry

A project is defined by Cleland and Kerzner as “human and non-human resources pulled
together into a temporary organisation to achieve a specified purpose” (1985, cited in Turner
& Müller, 2003, p.3). This definition will be used for this thesis as it draws attention to the
human interaction and the values and beliefs within the project and shows that a project is to
an extent defined by the people who belong to it. This is important to consider in connection
to risk identification as it is affected by values and beliefs (Maytorena et al., 2007, p.315).
Projects are also vessels for organisational goals, such as goals of change, resource utilisation,
uncertainty management, and of course the production function (Turner & Müller, 2003, pp2-
6). There are five major characteristics of projects as stated by Larson and Gray (2021, p.7).
The project must have (1) an established objective along with (2) a defined beginning and end

15
when it comes to the lifespan of the project. There are often (3) several different professionals
and departments involved in the project as it aims to (4) do something which has never been
done before. There are also (5) special requirements involved in projects when it comes to
time, cost, and performance.

To address the needs for adequate quality, compliance, and specific regulatory needs, the
pharmaceutical industry needs project management for projects to succeed (Chauhan &
Srivastava, 2014, p.56). Brown and Grundy (2016, p.16) argue that contemporary project
management is ideally suited for the pharmaceutical industry. Furthermore, to cater to the
implementation difficulty and the need for redefining the project once it has started, along with
the unique regulatory specifications, pharmaceutical projects should contain five key stages.
These five stages of what can be classified as the pharmaceutical project lifecycle, are defined
by Brown and Grundy (2016, p.17-20). They consist of (1) defining the project, (2) project
strategy, (3) detailed project planning, (4) control and implementation, and (5) learning and
review. Even though these stages show us the process of a pharmaceutical project from start to
finish, the pharmaceutical industry still has a long way to go when it comes to developing their
use of project management. The specification of project management for the pharmaceutical
industry is important due to the way that different environments and conditions it experiences
affects how project management influences pharmaceutical projects. This is important to know,
since the internal and external environment is where the temporary organisation scours for
potential risks and problems. The special requirements when it comes to, for example,
regulatory requirements mean that stages such as stage 3: detailed project planning, is needed,
which is not acknowledged as a part of ‘general’ project management. Specifications such as
stage 3 can also show us where the common risks unique to pharmaceutical projects may lie,
which is important as it is part of the purpose for this study.

As mentioned previously, we use the definition “human and non-human resources pulled
together into a temporary organisation to achieve a specified purpose” (1985, cited in Turner
& Müller, 2003, p.3) for a project. This is because this definition highlights the human aspect
of projects. The project is dependent on the people involved, especially the project manager.
Still, the project lifecycle does not just happen on its own. It needs to be conducted and
monitored by the project manager who plays an essential role when it comes to the success of
the project. This is also true for the pharmaceutical project manager, who’s role will be
described in the next sub-section.

3.1.3 Pharmaceutical project management

Project managers within pharmaceutical projects contribute with crucial knowledge for the
projects’ survival. According to project managers in the pharmaceutical industry in India,
quality, time, and cost are factors which they deem most important for a project’s success
(Chauhan & Srivastava, 2014, p.58). However, these project managers identified risk
management as much less important, identifying risk management to contribute with only 16%
to project success, compared to 76.36%, 89.94%, and 83.35% for the three previously
mentioned factors (Chauhan & Srivastava, 2014, p.58). However, as we have identified in 1.2
‘Arriving at the research problem’, along with what will be described regarding risk as a
concept, risk and risk management is crucial to the survival of project success. This is
something which Chauhan and Srivastava agree with, and they support our research purpose
by stating that risk management needs more attention in the pharmaceutical industry (2014,
p.58).

16
Since projects are different from the everyday operations of most organisations, they require
their own manager, called the ‘project manager’. The project manager’s job is in some ways
similar to other manager jobs, especially in the sense that it is the project manager’s
responsibility to make sure that the objectives and goals of the project are met (Project
Management Institute, 2021, p.4). However, the project manager’s role differs in the sense that
they need to work with a fixed lifespan, and they need to be able to manage and familiarise
themselves with the non-repetitive activities of the project (Larson & Gray, 2021, p.11). There
are pressures on project managers which may be more apparent and obvious compared to
regular managers because every decision that they make has a meaningful impact on the project
as the lifespan often is so limited. When projects are seen as temporary organisations, the
project manager also becomes the chief executive (Turner & Müller, 2003, p.5). This means
that they become responsible for setting goals and objectives along with delegating
responsibilities and motivating the project group members. Along with motivating their
subordinates, the project manager should also make sure that their authority is clear and
respected among the group members (Turner & Müller, 2003, p.5). Project managers in the
pharmaceutical industry need to be able to focus on the project at hand without being
overwhelmed by work outside of the project and are preferably people who have relevant and
long-lasting experience of project management and the pharmaceutical industry (Brown &
Grundy, 2016, p.60). This experience may be extra important compared to other industries as,
for example, the regulatory constraints are complicated and have massive effects on the project
if they are not handled properly. An important aspect of the pharmaceutical project manager
role beyond objectives and budgetary concerns, is to monitor the attitude and energy within the
project team. This needs to be considered to keep up morale for the good of the project (Brown
& Grundy, 2016, p.192).

Chauhan and Srivastava found that in their survey, 12% of their project manager respondents
had the view that project management has a low or moderate impact on project success, despite
the known importance of project management on project success (2014, p.57). This attitude is
also reflected in Cooke-Davies and Arzymanow, where both leadership and project
management capability of pharmaceutical projects score much lower compared to other
industries (2003, p.477). This indicates that not only does the practice of pharmaceutical project
management need to be researched and developed more, but project managers in the
pharmaceutical industry need to believe in the importance of project management for this to
materialise into project success.

There are many important properties of a pharmaceutical project manager. Experience is one
that is especially important as mentioned by Brown & Grundy, (2016, p.192). This is because
of industry-specific conditions such as regulatory rules and regulations. However, there is a
gap in the literature when it comes to pharmaceutical project managers and the impact that their
experience has on their risk identification performance.

3.1.4 Experience and risk identification

Experience is a factor which is quite prevalent when looking into the phenomenon of risk
identification, especially in pharmaceutical project management as mentioned above.
However, the causal relationship between experience and risk identification performance is
debated amongst researchers. Furthermore, there are other indicative factors of a project
manager which affect the success of a risk identification process.

17
Chapman (1990) and Al-Tabtabai and Diekmann (1992), both argue that experience of a project
manager does have an impact on the identification of risks (cited in Maytorena et al. 2007,
p.316). They argue that professional training, knowledge, and most importantly, experience of
the project sector over time all influence a project manager’s ability to identify risk. Despite
that, Maytorena et al. (2007, p.322) demonstrate that there is no significant association between
risk identification performance and previous project management experience which is defined
by a project manager “age, years in management, years in job title” (Maytorena et al., 2007,
p.322). The style of information search used in risk identification within project and risk
management is very important as this plays a large part in the success of the risk identification.
Also, there are factors outside of managerial experience which affect the style of information
search. These factors are risk management training and the graduate level of the project
managers which both have positively correlated relationships with risk identification success
(Maytorena et al., 2007, p.323).

Project managers that are graduates tend to alternate between both feedback style and
information search style in order to identify risks, while non-graduates are not as keen to use
any of the styles (Maytorena et al., 2007, p.321 & 323). Compared to graduates, non-graduates
identify risks that are based on any type of information search to a larger extent, wherein the
risks are identified grounded in their past personal experience (Maytorena et al., 2007, p.321).
This argument is supported by Hoon Kwak and Dixon, (2008, p.553) who also argue that risk
identification is often based on past experiences when it comes to risk, resulting in novel risks
not being identified to the necessary extent. This is important since it is impossible to say,
without an adequate risk assessment, whether these ‘new’ risks can jeopardise the project
objectives (Raz et al., 2002, p.101). What is unquestionable though is risk and uncertainties
presence within the project, it would be absurd for a project manager to believe that no risks
will emerge when managing a project (Brown & Grundy, 2016, p.128). Despite that, it is
reasonable for project managers to find some difficulty with addressing how risks and
uncertainties evolve during the project life cycle, since they are not always constant. The
following part will bring depth to risk and uncertainties within the project and how they tend
to progress during a project.

3.1.5 Risk and uncertainties within projects

Risks are present and need to be managed in every organisation. As stated, projects have
increased among organisations. Especially since companies strive to improve their market
share and increase profit by improving processes and their product towards the customer
(Mohammad Sabbaghi & Allahyari, 2020, p.111), and projects are a useful tool of the
customised demand society has developed. However, since projects differ from routine, they
often contain more risks. Even more so, considering projects have time-bound objectives and
requirements to accomplish which results in time-bound choices and pressed decisions.
Generally, the time-objective in projects could be defined as the ‘critical path’. The critical
path is the activities that take the longest and, if delayed, will likely affect the timeframe for
the entire project (Brown & Grundy, 2016, p.118). Pharmaceutical projects are typically
complex at a technical level and instead of addressing the critical path before a project starts,
pharmaceutical projects have the tendency to straighten out the most crucial part of the project
along the way (Brown & Grundy, 2016, p.118). Dealing with the risk along the way means
jeopardising the project, even more so since pharmaceutical projects are complex - risks are
more present.

18
When starting a project, the people involved should be aware of how risks behave during a
project, in order to optimise the project and the work. Risk and uncertainties have a way of
aligning with the project life cycle. They are present throughout the project, but particularly
apparent in the earliest stages, the defining and planning stage (Chapman & Ward, 2003, p.7).
The possibility of a risk appearing is at its highest during the early stages. (Larson & Gray,
2021, p. 214). As the project proceeds, the risk declines since uncertainties gradually disappear
and solutions about critical issues are determined. The major disparity between risk and
uncertainty is that risk, unlike uncertainty, can be associated with probability. Risk, however,
can be defined very differently on a case-by-case basis (Chapman & Ward, 2003, p. 7) since
risk consists of both unpredictability of the future and inexperience of impact. Opposite to risk,
which decreases during a project, the cost impact of a risk event increases over the life of the
project (Larson & Gray, 2021, p.214). These two concepts make up the Risk Event Graph, see
figure 1. A mismanaged risk control in the beginning of a project could therefore be largely
detrimental for a project if it occurs at the end of the project. Emphasising that risk management
should be a proactive system, rather than reactive. A successful management of project risk not
only reduces negative consequences of undesirable events, but also helps the project manager
to prepare them to act when an advantage is possible and control the future in a better way, to
enhance the chance of meeting the project objectives (Larson & Gray, 2021, p. 215). Brown &
Grundy, stating that by managing a risk of a project, you actually manage the entire project
(2016, p.123).

Figure 1. Risk Event Graph (Larson & Gray, 2021, p. 215)

Projects have the capability to streamline risk management, which could be a contributing
factor for its emerging popularity. However, to do the streamline as successfully as possible,
one must separate the different types of risk.

19
 3.1.6 Classifying pharmaceutical risks

To enable the efficiency of risk management for companies, it is necessary to classify the
different types of risk (George, 2020, p.975. The pharmaceutical industry consists to a large
degree of creation and production of drugs, which revolves around projects. One must therefore
classify the risk in order to manage it correctly. According to Mohammad Sabbaghi and
Allahyari (2020, p.112) there are several risks involved in production project management.
However, they have labelled the risks into five categories: supply risk, process risks, demand
risk, control risk, and environmental risks (2020, p.112). The supply risk is the most important
risk to mitigate in production since it can affect the whole project. The risk of raw materials
not being supplied as expected can be a result of other risks (Mohammad Sabbaghi & Allahyari,
2020, p.112). The process risk is when the product has not been produced to meet the
expectations on time or quality. Continuously, demand risk is more of an external risk, meaning
the risk from lack or shortage of demand for a special product. Thereafter, the control risk is
the result of insufficient quality control. Lastly, environmental risk which is the risk of
environmental effects that can result from physical, social, political, legal, operational, and
economic environment. These five risks establish the challenges a project can face during the
executing stages of a project. However, Mohammad Sabbaghi and Allahyari (2020, p.112) has
developed additional types of risk involved in production projects management. Presenting the
common risks that are managed in pharmaceutical production projects, while also covering, to
a certain extent, more areas that a project consists of, see table 2. For example, the covid-19
pandemic could be categorised as an environmental risk that emerged. As mentioned, the
pandemic caused supply-difficulties in the pharmaceutical industry, generating delays for many
projects and companies, which could indicate a ‘transit time’-risk according to table 2. Even
though table 2, combined with previous five categories of risk, covers many different types of
risk, one should be aware that the sources of project risks are unlimited. Especially since risk
is subjective, a certain risk may be categorised differently depending on the person performing
the evaluation to one person (Campbell, 2006, p.227). Thus, one type of risk can also be
categorised to another type. Since companies nowadays have the tendency to only perform
superficial risk assessments, there is a chance that they respond to a risk that is wrongfully
viewed. According to Stulz (2008, p.41) wrongfully viewed risk could result in important risks
being ignored and as shown, ignored risk could be harmful for a project, both financially and
timewise.

20
Table 2. Risks involved in production projects management (Mohammad Sabbaghi and Allahyari, 2020, p.112)

Risk Definition

Financial Change in exchange rate

Transit time Change in the transit time including the transportation and clearance

Forecast Errors in needs estimation that resulted in over- or underestimate inventory

Quality Damaged, unfinished, and different products, part, or material in different areas

Safety The products that endanger safety

Disruption in business Inability to produce or selling the product to customers

Survival Factory bankruptcy

Tools and inventory Disagreement about the inventory ownership, overuse of vehicle owned by others
ownership

Culture Insufficient information about people, culture, and language

Opportunism The supplier’s opportunistic behaviour with customers

Oil price Change in oil price

Hopefully the risk is viewed correctly, which would enable the right risk assessment.
Nonetheless, before viewing or deciding on the category of the risk, one must find the risk. The
searching of risk is a part of the risk identification (Hoon Kwak & Dixon, 2008, p.553).

3.1.7 Risk identification techniques in pharmaceutical projects

Research concerning the risk management process argues for its importance, while
simultaneously being underdeveloped. According to Brown & Grundy (2016, p. 123), risk
management for pharmaceutical projects is “the systematic application of policies, procedures,
methods and practices to the tasks of identifying, analysing, evaluating, handling and
monitoring risk”, also known as the risk management process. The risk management process
simplified is the process of identifying risk, making the assessment of risks impact and
likelihood, how the response to risk should and lastly creating a response control system
(Larson & Gray, 2021, p.216). We have, as mentioned, chosen to focus on the identification of
risks, due to the lack of research there is within the subject in comparison to the other parts of
the risk management process. According to Maytorena et al. (2007, p.315) numerous best
practice standards, guides, tools, and techniques have been developed to make the project risk
management process more effective. However, they display that most of the instruments
created only address the analysis phases of the risk management process and not the
identification phase. Even though the analysis phase is completely dependent on that the
identification of risk has been accurately conducted in the first instance (Maytorena et al., 2007,
p.315).

21
Searching for risk, which is one of the two tasks of identifying risks, can be supported by
several techniques and tools. The most common and suitable for pharmaceutical projects
consist of (1) consulting, (2) risk profile (3) critical path method and, (4) historical data
(Brown & Grundy, 2016, p.123; Maytorena et al., 2007, p.351; Charoo and Ali, 2012, p.948).
The overall atmosphere and mindset when working in a pharmaceutical project with identifying
risk is to work according to Murphy’s Law, meaning that ‘anything that can go wrong, will go
wrong’. Therefore, possible assumptions will be tested and considerations about the project
environment and future scenarios will be made (Brown & Grundy, 2016, p.124). Even though
an optimistic attitude is preferable at the implementation and execution of the project, critical
thinking is more suitable when identifying risk since the purpose is to find potential problems
before they happen (Larson & Gray, 2021, p.219).

Consulting
Asking people in the team is one way of the different searching approaches (Brown & Grundy,
2016, p.123). Research has been found that demonstrates that groups are more superior in
finding risk than the individual. Teams make more accurate appraisals than individuals and use
techniques such as brainstorming with an open mind to identify as many potential risks as
possible (Larson & Gray, 2021, p.216; George, 2020, p.975; Maytorena et al., 2007, p.316).
Which also indicates that the identification process is not duty-bound to just the core team.
However, the drawback of brainstorming is the chance of developing groupthink (Maytorena
et al., 2007, p. 316; Larson & Gray, 2021, p. 420) Searching for risks would benefit by input
from stakeholders and is therefore something the core team should desire (Larson & Gray,
2021, p.212). Senior management, the project team and other stakeholders should be deeply
involved with identifying risk to ensure that all perspectives have been explored and considered
(George, 2020, p.977). Involving stakeholders, for example through interviews, makes them
more committed to the project success while also acquiring their perspectives. According to
Rezakhani (2021) and George (2020, p.975), expert interviews are one of the main sources of
risk detection which indicates how important consulting and getting other people input on the
project is for reaching the project objectives (Maytorena et al., 2007, p.316). Stakeholders have
the tendency of being partial, affected by their feelings. Therefore, by including expert
interviews, one combined several perspectives on the project and minimise the chance of
collecting biased opinions. Additionally, experts usually have an academic foundation to stand
on when they make statements, making their opinions more trustworthy.

Risk Profile
Another advantageous technique to detecting risk within pharmaceutical projects is a risk
profile (Brown & Grundy, 2016, p. 124). The risk profile is a list of questions that consider
several traditional areas of uncertainty on a project (Larson & Gray, 2021, p. 217). This can
also function as a checklist, which is classified as one of the most used risk identification
techniques used over the past two decades (Maytorena et al., 2007, p.316). The questions
included in the risk profile, are usually based on previous similar projects that have been
executed (Larson & Gray, 2021, p. 217). An effective risk profile is a profile that has developed
and refined questions that will disclose strengths and weaknesses for the projects that are
presently managed. The benefit of having a well-established risk profile is that it can consider
several departments for the projects, making the project team contemplate various perspectives
that will provide new identified risks (Larson & Gray, 2021, p. 217). Risk profiles are beneficial
because they can be tailored to account for the specific industry’s important aspects (Brown &
Grundy, 2016, p.124). Even though the risk profile is based on previous similar projects, which
can be profitable, it can also be a drawback. To be useful, the risk profiles must be updated and

22
refined, which normally is conducted by the personnel from the project office (Larson & Gray,
2021, p.218). If they are not up to date, using the risk profile has the potential to be irrelevant
for the project at hand. One condition which needs to be met for a project to be called a project
is that it is novel in some way (Larson & Gray, 2021, p.7). This means that risk profiles, which
are based on previous events and experiences, cannot be used alone if one wants to conduct a
thorough risk identification.

Since the risk profile will not be enough to cover the identification of all risks, it can be
combined with other techniques and tools. Looking into the activities included in the critical
path, one can identify additional risks (Brown & Grundy, 2016, p.123).

Critical Path Method (CPM)

The Critical Path helps create and visualise the project network (Larson & Gray, 2021, p.171).
The Critical Path consists of determining the total duration of a project and which activities
that are dependent on each other. To find the critical path one must define the least amount of
time necessary to complete each task with the least amount of slack in the project, commonly
referred to as the critical path method (CPM) (Larson & Gray, 2021, p.172; Sara, 2012, p.6).
Meaning that, if one activity is delayed, the whole project is delayed with the same amount of
time (Larson & Gray, 2021, p.172). All activities in the project combined creates a schedule of
the project, which then visualises which activities are more sensitive regarding time and thus
carries a greater risk of sabotaging the project. What CPM also enables is improved resource
management (Brown & Grundy, 2016, p.129). In some projects, activities are planned parallel
while not considering that the resources may not be enough. This can result in a delayed project
due to the fact that one must have waited for resources to be available. Therefore, by conducting
the CPM, one might notice a resource gap which, if not filled, could lead to a significant delay,
but is then giving the opportunity to plan more properly (Brown & Grundy, 2016, p.130).

Brown & Grundy (2016, p.130) have found that pharmaceutical projects often have the
perception that everything will happen on time. Implying that preparation and planning is not
always possible. CPM primarily creates estimation of the future (Sara, 2012, p.7), therefore the
CPM can additionally be used as a schedule where certain checkpoints need to be made, to
double-check and ensure that resources and the schedule is proceeding as planned (Brown &
Grundy, 2016, p. 130). However, since CPM mainly highlights the time objective for a project,
supplementary techniques, and tools to find possible risks are required to a project.

Historical Data
Historical Data is one of the main sources of detecting risk (Rezakhani, 2021; George, 2020,
p.975). Historical Data is based on risk registers, databases and archives conducted by
previous similar projects in the past (Larson & Gray, 2021, p. 219). When formal risk profiles
are not available, historical data can be used as a compliment. Project teams can then explore
what went or could go wrong on similar projects as a way of detecting potential risks (Larson
& Gray, 2021, p. 219). Risk register is a part of historical data and a tool to document risk and
address suitable methods to respond to the risk (George, 2020, p.975). Risk registers consist of
four categories; risk, risk identified, risk causes and risk responses (George, 2021, p.975). The
use of historical data is many, but the main ones are that it plays a strategic role in making
project decisions, gives direction to the project team in the management of risks throughout the
project and enables project stakeholders to better understand the impact of project risks
identified (George, 2020, p. 975). Even though the usages of historical data are advantageous,
it should be emphasised as mentioned previously, that historical data should merely be used as
23
a complement. Either a complement when formal risk profiles are not obtainable, or when
additional perspectives of the project are needed. Historical data cannot alone be the technique
or tool used, since it relies on past conditions, therefore not always fully applicable to new
environments and projects.

3.1.8 Concluding remarks

What previous sections have shown is that the importance of being thorough when it comes to
risk identification can never be overstated within pharmaceutical project management, due to
its direct effect on project success. Risk identification can be influenced by different factors,
such as context and the relevant industry. From this theoretical chapter, we can deduce that the
risk identification process is affected by the fact that it exists in a certain industry, i.e.. the
pharmaceutical industry. Due to the industry-specific conditions, pharmaceutical risk
identification needs continuous attention. Thereby, managing risk should be something
proactive, not reactive in order to help a project as much as possible to reach the project
objective of time, cost, and scope. Therefore, identifying risk at the earliest stage possible, can
help projects to survive. Previously in this theoretical chapter, we have discussed risk
identification and pharmaceutical project management. However, we have not explored these
phenomena in the context of our thesis. In 3.2 we will discuss how risk identification in
pharmaceutical projects may be influenced by the relevant contexts, which are the Covid-19
pandemic and Sweden as the geographical location.

3.2 Contextual influences on pharmaceutical project risk identification

(PPRI)
As Zahra (2007, p. 443) states, understanding the nature, dynamics, uniqueness, and limitations
of a situation can enrich future studies. Thereby, to enrich our study and give it more depth, we
explore the topics of pharmaceutical project risk identification in the relevant contexts of time
and place, being the Covid-19 pandemic and Sweden as a geographical location. Exploring the
phenomena which are being studied without connecting these to relevant contexts means that
a dimension of the research is lost, especially for the reader (Zahra, 2007, p.445). Exploring
contextual influences also means that one avoids attributing a result to a phenomenon such as
pharmaceutical project management, when in actuality it is produced as a result of contextual
factors. Therefore, this study will highlight the contextual influences on our chosen topic, in
hopes to enrich our research contribution.

3.2.1 PPRI and the Covid-19 pandemic

The Covid-19 pandemic has had meaningful impacts on the pharmaceutical industry. Some
short-term impacts include changes in demand, supply shortages, changes in regulations, panic-
buying of medical supplies, and changes in the research and development process (Ayati et al.,
2020, p.800). There have also been predictions regarding the long-term impacts of the
pandemic on the pharmaceutical industry. These include delays of approval, the slow-down of
the pharmaceutical industry growth, and changes in consumption (Ayati et al., 2020, p.802).
The impacts mentioned above all pose risks which the pharmaceutical industry must deal with
at one time or another. However, in complex projects such as pharmaceutical projects, risks
tend to be interconnected, and can thereby create positive feedback loops, which make the risk
identification process more challenging (Williams, 2017, p.56). Thereby, the risk identification
process in the pharmaceutical industry must consider and predict the possibility of
interconnectedness between individual risks that are identified.

24
Within projects, decision-makers often operate under individual cognitive frames, which are
their means for making sense of their environment when the current information is of an
ambiguous nature (Kaplan, 2008, p.729). These cognitive frames can be determinants of how
decision-makers perceive their environments and how they make decisions during times of
uncertainty (Kaplan, 2008, p.729). Similarly, Campbell (2006, p.225) also discusses the partial
subjectivity of risk, which mirrors the argument of cognitive framing. Subjective views on risk
and cognitive frames can therefore be argued to have impacts on what decision-makers such as
pharmaceutical projects managers see as risks, and how these are identified. The risk
identification process is an important component of risk management which must be done well
for the project to succeed (Picciotto, 2019, p. 474). This means that the success of these projects
during the Covid-19 pandemic has very much depended on who the project manager and other
project members are and what their capabilities and characteristics are when it comes to risk
identification.

Since risk is given a numerical value based on the likelihood and impact of the risk occurring
(Williams, 1996, p.185), the partial subjectivity of risk and cognitive frames can be argued to
have a direct impact on how risks are handled in individual cases. This claim is also supported
by some of the risk identification techniques that are used in pharmaceutical project
management, since these often are grounded in historical data and experience (Charoo & Ali,
2012, p.948). This indicates that the information which has been/is available during the Covid-
19 pandemic may not be as helpful as one might think. Since many pharmaceutical project
managers have needed to deal with unprecedented risks regarding the pharmaceutical industry
during the course of a pandemic due to its novelty, one may argue that experience has become
less useful compared to other qualities. Furthermore, the classification/categorization stage of
risk identification is partly based on predictability (Maytorena et al., 2007, p.316), which
subsequently indicates that risk identification during the Covid-19 pandemic has become
significantly more difficult.

An exception from the increasingly difficult risk identification within pharmaceutical projects
has been projects concerned with the process of developing vaccines against the Sars-cov-2
virus. These projects were ultimately risk-free, since governments all over the world purchased
vaccines in advance along with providing funding for these projects (Winch et al., 2021, p.3-
4). These specific projects had different project life cycles due to the ability to omit threats
from the external environment, which meant that the amount of time between the beginning
and end of these projects could be significantly reduced (Winch et al., 2021, p.4). The
pharmaceutical industry is generally seen as an industry that is unwilling to take risks. This can
also impact the speed of the decision-making in the industry (Dorabjee et al., 1998, p.209). Fast
decisions are needed in a situation such as the Covid-19 pandemic, and this has likely meant
that risk identification has been conducted at several different stages of pharmaceutical projects
as an effect of the pandemic’s changing environment. However, the lack of risk involved in the
Covid-19 vaccine projects may therefore have been behind the unprecedented speed of the
vaccine development and rapid decision making.

It is important to contextualise Pharmaceutical Project Risk Identification when it comes to the

Covid-19 pandemic as the combination of the two may have unique implications for
pharmaceutical projects. It is also important to contextualise PPRI in terms of the geographical
location, being Sweden in this case. This will be explored further below.

25
 3.2.2 PPRI Sweden as a research context

We chose Sweden as the context for our study for several reasons. First and foremost, the
Swedish risk management decisions are highly influenced by the government, aligning with
Sweden's risk legislation, which is among the strictest in Europe (Lofstedt et al., 2000, p.159).
The unique constellation of experiences each and every project represents originates from the
structural characteristics of the projects but also from the social and political environment the
project is within (Picciotto, 2019, p. 477). Resulting Swedish pharmaceutical project to be
within an intriguing political environment.

Secondly, Sweden is a part of a quite complex system for the authority involved within the
pharmaceutical industry. As for Sweden, a member of the European union, the European
Federation of Pharmaceutical Industry and Associations (EFPIA) implements directives,
regulations, and recommendations which the Swedish government and subsequently the
Swedish Medical Products Agency (MPA) has a responsibility to enforce (Zetterqvist &
Mulinari, 2013, p.2). The European Commission has developed national codes, rather than
having one large body of regulations (Brown et al., 2009, p. 549). The European Commission's
approach is “comply or explain”, meaning that member states have the authority to not fully
obey EFPIA directives however an explanation, to why they will not obey, is then needed
(Brown et al., 2009, p. 549). As a result, in addition to being aligned with Swedish and
European Union marketing and pharmaceutical regulations, the Swedish pharmaceutical
industry is also in compliance with the international industry codes of practice (Zetterqvist &
Mulinari, 2013, p.2). In fact, the MPA, has delegated their responsibility on enforcing the
regulations to the Swedish Association of the Pharmaceutical Industry (LIF) (Zetterqvist &
Mulinari, 2013, p.2). Resulting in an industry which is highly governed by authorities. The
World Health Organisation (WHO) has estimated that 25 % of the medicines consumed in
developing countries is counterfeit (Gautam et al., 2009, p.251). Counterfeit medicines include
drugs which have been rejected by regulators or manufacturers. Fortunately, counterfeit
medicines do not originate from Sweden, approximately 75 % originates from India (Gautam
et al., 2009, p.250), thereby displaying the success of the Swedish pharmaceutical industry
system.

Third, the pharmaceutical export industry is growing in Sweden. During 2020, the Swedish
pharmaceutical industry broke new records in exports while the general export for Sweden
decreased (lif, 2022). Demonstrating what Lofstedt et al. (2000, p.159-160) stated, that the
globalisation combined with Swedish high standards results in an increase in exports while also
hampering imports, as regulations might increase costs. Therefore, the government's
involvement in the industry, setting high standards to meet, results in raised prices. When the
pharmaceutical expenditure grew significantly in Sweden, it could be traced to new expensive
drugs being launched on the market (Wettermark et al., 2008, p.538). However, high
regulations not only increase the final price for consumers, but also raises the caution when
pursuing a project since there are more financial resources involved. The pharmaceutical
industry is generally an industry that is hesitant towards risks (Dorabjee et al., 1998, p. 209).
Cautiousness contributes to a thorough risk management (including risk identification), or at
least to the desire to make a more thorough one, as studies have shown that risk management
is often mainly carried out to get the project approved (Hoon Kwak & Dixon, 2008, p.553).
Being more cautious can be beneficial when managing risk, however the pharmaceutical
industry is depending on innovation and the development of new medicines (Cardinal &
Hatfield, 2000, p.248-249), which creates a dilemma. Innovation is often associated with taking
risks (Borgelt & Falk, 2007, p.123), while the pharmaceutical industry is cautious and hesitant

26
towards risk. Hesitation towards risk results in longer processing time when making decisions.
To make the decisions more efficient, risk management could act as a guide for pharmaceutical
projects, similar to risk management within companies (Sultz, 2008, p. 40).

Lastly, not only does globalisation affect Swedish exports but it also increases vulnerability to
risks since an organisation becomes more open to the whole world (Norrman & Jansson, 2004,
p.435). Companies, organisations, and projects should no longer only focus on their own risks,
but also the risks other actors have if they are included in one's supply chain (Norrman &
Jansson, 2004, p.435), since their risks can indirectly become our risk. Well-defined problem
objectives facilitate both using appropriate risk management tools and identification of risks
(Charoo and Ali, 2012, p.948). Emphasising the importance of a well-established base when
conducting risk management. The basis for risk management is highly founded on the initial
part, risk identification, which is the component that can make or break a project's success
(Picciotto, 2019, p. 474). Since the world is nowadays more “open” due to globalisation, the
demand for established risk management has been enhanced considering that projects are more
vulnerable and can be affected to a higher extent by external factors. Therefore, organisations,
both temporary and permanent, should prioritise managing risks since it can prevent project
failure.

3.2.3 Concluding remarks

Addressing Sweden as the geographical area during the Covid-19 pandemic will contribute to
an intriguing study due to its complex environment. The projects to develop vaccines against
the Sars-cov-2 were ultimately risk-free projects due to governments all over the world
providing funding and therefore protecting projects from failure. However, the covid-19
pandemic has affected additional parts of the society and is considered to cause long-term
impacts on the pharmaceutical industry, i.e., delays of approval and slow-down of the
pharmaceutical industry growth. Delays of approval due to the pandemic can be combined with
Sweden as a geographical area since Swedish risk management decisions are highly influenced
by the government and during 2020 Sweden saw a growth in the industry. Therefore, the two
contexts, separated and combined, have the capability to influence our topic and by
highlighting them we hope to enrich our research contribution.

27
4.0 Practical methodology
In this chapter, practical methodological choices will be presented. Initially, we will present
our general methods for data collection and the reason for choosing the method. Thereafter,
the selection of our participants is presented along with how the interviews were conducted.
Lastly, a step-by-step of our data analysis is provided, followed by the research ethics we have
aspired to obtain.

4.1 Data collection methods

To ensure that the research question is answered, and the purpose fulfilled, researchers need to
recognise that the chosen data collection method is a fit with the philosophical assumptions
(Howard-Grenville et al., 2021, p.1315). We have approached the data collection method in a
way that continuously acknowledges and goes in line with our philosophical assumption,
interpretivism. This is done to ensure that we use data collection methods that are the most
suitable for our specific study. We argue that existing data is inadequate to answer our research
question concerning risk identification in Swedish pharmaceutical projects in connection with
the Covid-19 pandemic. Additionally, we intend to gain a deeper understanding concerning
pharmaceutical companies' ability to identify risk in their projects, and how that has changed
because of the covid-19 pandemic. Therefore, primary data has been acquired, giving us the
greatest chance of answering the research question. Secondary data, such as data sets from
previous studies or pre-existing databases (Collis & Hussey, 2014, p. 196-197), can be useful
as a complement to the primary data in the study. Since qualitative data requires context to be
understood (Collis & Hussey, 2014, p.130), background information needs to be collected first.
Therefore, secondary data will be used as a basis for contextualising the primary qualitative
data in our study.

The primary data being collected for this study was through interviews. More specifically, we
carried out semi-structured interviews. This is suitable when considering our interpretivist
approach to the research we conducted, as we aim to gain a deeper knowledge surrounding the
subjective realities of our respondents when it comes to project risk identification in their
industry. When approaching the research in an interpretivist manner, the type of data to be
collected is qualitative. Semi-structured interviews are the most common and appropriate way
to gain a deeper understanding about the topic of investigation, and semi-structured interviews
give the interviewer some freedoms (Collis & Hussey, 2014, p.133). For example, the order of
the questions can be altered to better fit the natural flow of the conversation while still giving
it some direction, and the questions used in semi-structured interviews are often open ended.
This means that the answers which are prompted go beyond a simple ‘yes’ or ‘no’, and are
often more in-depth and personal, providing the researchers with extensive knowledge about
the topic based on the respondent’s experiences (Collis & Hussey, 2014, p.133). Semi-
structured interviews also give us the opportunity to use probing questions if we want the
respondent to develop an answer further, including questions which ask why, how, and if the
respondent can provide examples (Collis and Hussey, 2014, p.136). Additionally, a semi-
structured method is also preferable since there is no follow-up interview. The interviewer can
then confirm or clarify continuously throughout the interview without jeopardising the
interview guide (Saunders et al., 2019, p. 434).

Two of the most common other options when it comes to conducting interviews are the
structured and unstructured interview. We argue that these types of interviews do not fit our
study. This is because in the structured interview, the interviewers ask the same questions in

28
the same order, and there is a possibility of missing important information if one does not allow
the interview to stray in the slightest from what is planned. The structured interview is also
more associated with the positivist paradigm, which we are not using (Collis and Hussey, 2014,
p.134). The reason why we will not be using the unstructured interview is because in this type
of interview, the interviewer does not prepare questions in advance, and must develop them
during the course of the interview. This makes it very difficult to take notes and to fully absorb
the information which the respondent is providing. This type of interview also means that it is
likely to miss crucial information that the respondent may have but does not share unless asked
the right questions (Collis and Hussey, 2014, p.133).

The collected primary data is non-numerical for two main reasons. Firstly, non-numerical data
goes in line with the interpretivist paradigm, and secondly, we argue that the decision to use
non-numerical data gave us the opportunity to collect all kinds of information regardless of if
it is measurable or not. The reason behind not collecting numerical data is because the
subjective realities of the respondents cannot be measured, and they are far too complex and
intricate to distil into a numerical value, which is the essence of numerical data (Collis &
Hussey, 2014, p. 130). This is also one reason which explains why we did not opt for the
positivist paradigm. Considering all the participants have different experiences and views on
risk identification within pharmaceutical projects, interviews were more appropriate since it
aligned with the subjective approach.

4.1.1 Sampling technique

Since we conducted an analytical qualitative study, our aim was to obtain further knowledge
concerning a specific topic, which requires participants with experience and knowledge.
Therefore, it would be impractical for us to study the whole population, highlighting the need
for a separate part of the population; a sample (Bell et al., 2019, p.409). In our degree project
we first and foremost chose to conduct a purposeful sampling, as a method to ensure that our
sample was relevant for the research we were carrying out. Meaning that we used our
judgement when choosing participants, we believe were able to answer our research question.
Purposeful sampling is the most common sampling method for qualitative research (Bell et al.,
2019, 391). With purposeful sampling we had the opportunity to actively include appropriate
participants which we believed were able to answer our research question (Bell et al., 2019, p.
408). Our selection of participants was based on three criteria that need to be upheld.

Firstly, the companies we included were companies that operate within Sweden. As explained,
the covid-19 pandemic has implied different regulations and restrictions depending on the
country. Therefore, with the intention to assemble comparable data, we required that all
companies had been active on the same market. Secondly, our respondents needed to be active
in the pharmaceutical industry. By active, we mean that the organisations/individuals
participating in the interviews must have been a part of projects which have taken place both
before and during the Covid-19 pandemic. Additionally, since we aspired to investigate the
activities, pharmaceutical projects performed when identifying risks, it is of relevance that the
respondents also are active within pharmaceuticals. Previous studies, as mentioned, have
shown how several parts of the pharmaceutical industry have failed to achieve knowledge about
project risk management. Therefore, we decided to not make any limitations within the industry
i.e., only focusing on researching pharmaceutical companies, to enable a holistic view of the
industry. This criterion was implemented with the purpose of getting in contact with an
environment that is highly engaged with risk. The participants we conducted interviews with,
all originated from pharmaceutical companies and were either a manager or a member of

29
pharmaceutical projects. This provided us with the holistic view of how a pharmaceutical
project operates and enabled us to establish the theory we present in future chapters.

When the research, concerning appropriate participants, was initiated through the trade
association for the pharmaceutical companies in Sweden, Lif, we developed knowledge about
organisations and whether they fulfilled the earlier stated criterion. Subsequently, we contacted
suitable companies through email, and other suitable individuals via LinkedIn. We asked them
if they were willing to participate and informed them about our degree project and the criteria's
they need to fulfil through an information form. Through the contact we could therefore
confirm and distinguish if they have the possibility to participate in an interview. Eventually,
if not addressing the appropriate manager, we requested the manager to forward our request to
people they thought had knowledge and experiences regarding risk identification within
pharmaceutical projects. The individuals that then accepted to participate in our study,
contacted us to determine time and place to conduct the interview and signed a consent form,
agreeing on the terms of participating in our research. Both the information form and the
consent form used towards our participants can be found among the appendices, specifically
appendix two and four.

Our choice of purposeful sampling relates to a non-random sampling. When a sampling frame
is difficult to identify in advance, random sampling becomes impossible and therefore a non-
random sampling is applicable (Collis & Hussey, 2014, p.198). There are several reasons why
non-random sampling was beneficial for our research. Firstly, since we did not intend to
generalise from the whole population it was more suitable for us to directly contact the
participants who might provide appropriate data. On the contrary, in positivist studies, it is
more appropriate to use a random sampling method since the goal is to generalise from the
population (Collis & Hussey, 2014, p. 194). Secondly, with non-random sampling techniques
we had the possibility to find participants that satisfied our criteria. Lastly, the non-random
sampling is a relevant method relating to the interpretive paradigm since the focus was
concerning the experience and the knowledge the participants had on the phenomenon (Bell et
al., 2019, p. 34; Collis & Hussey, 2014, p. 197). Thus, this sample technique was most suitable
to the purpose of providing insights into the beginning stages of risk management for projects
during Covid-19 in Sweden, within the pharmaceutical industry.

Besides purposeful sampling, snowball sampling has been used as a complement to purposeful
sampling, due to the essentiality of including people with experience of our phenomenon
(Collis & Hussey, 2014, p. 132). Snowball sampling consists of asking the participants in the
study if they are aware of anyone who has similar experience or knowledge and if they can
assist in linking us together (Collis & Hussey, 2009, pp. 199). We considered snowballing to
be an appropriate method due to the large networks project managers usually have (Larson &
Gray, 2021, p.11). Meaning that project managers tend to establish a network where all
stakeholders are included, therefore the manager we created contact with could, with high
probability, establish a contact with further managers or people with experience of projects.
Additionally, to the first two non-random sampling, snowball and purposeful sampling, there
is natural sampling (Collis & Hussey, 2014, p. 132). Natural sampling technique refers to when
researchers have negligible influence on the composition of the sample (Collis & Hussey, 2014,
p. 132). Our participants are required to have certain experience with the phenomenon
concerning risk identification in pharmaceutical projects. Therefore, we judged natural
sampling to not be adequate for the purpose in the study.

30
Conversely, random sampling is an additional method where the entire population has an equal
chance to be asked to participate (Collis & Hussey, 2014, p.51). Random sampling relates
highly to positivism since the goal is most commonly to generalise the population (Collis &
Hussey, 2014, p.197). However, random sampling requires a defined suitable sampling frame
(Collis & Hussey 2014, p. 197) and is appropriate when a specific category of people is not
sampled in the research question (Bell et al., 2019, p. 389). Thus, for our degree projects we
deemed random sampling to be inappropriate.

Lastly, the sample size of the study is important to acknowledge and decide upon. A sample
size in qualitative research can depend on different factors. In some studies, a sample size is
determined in advance based on the desire to secure saturation in the research. Saturation is
achieved when new interviews will add minimal or no new information (Aldiabat and Le
Navenec, 2018, p.247). Bell et al. (2019, p.398) claims that when striving for research
saturation, a sample size is unnecessary to specify, considering that saturation cannot be given
in advance. Saturation can be achieved early in the research or sometimes not even if a large
sample size is obtained, therefore it is difficult to know beforehand. On the other hand,
saturation might not always be needed in a study. Saunders et al (2019, p. 315) deems that not
achieving saturation can be seen as an indicator that the phenomenon has more research
opportunities. Our degree project did not strive to reach the saturation point, as there were time
constraints which prevented this. Furthermore, the population of people who work in projects
within the pharmaceutical industry in Sweden massively exceeded the time and resources we
possessed, rendering the saturation point unrealistic in our case. However, we aimed towards
gaining a deeper understanding of the topic by conducting eight interviews which are realistic
for our time constraints. Additionally, Hagaman and Wutich (2016, p. 205) assures through
their study that six to sixteen interviews are reasonable.

4.1.2 Conducting the interviews

The most suitable way of carrying out interviews in a qualitative study such as this one, is face
to face. This is because it allows the participants to see each other and makes it easier to form
a trusting relationship, while also resulting in more potential participants becoming actual
participants (Bell et al., 2019, p.621). Since the participants for our study were scattered around
Sweden we conducted the interviews through videoconference devices, such as Zoom to avoid
time consuming travelling (Collis & Hussey, 2014, p. 134). Even though face-to-face
interviews are advantageous, remote meetings have its benefits and, in our case, it has enabled
higher participation from other geographical areas (Solarino & Aguinis, 2021, p. 663). When
conducting interviews remotely one can choose between videoconference devices or phone
calls. All our eight interviews were carried out as a videoconference call. According to
Solarino & Aguinis (2021, p.663), videoconference is the preferable option since it allows us
to absorb the non-verbal expressions. The meaning of their statements may therefore be easier
to analyse (Bell et al., 2019, p.471). Nevertheless, phone calls can reduce biases due to the lack
of visual contact which can be a relief for participants. All things considered, we judged that
our thesis benefitted the most from the video conference option.

In respect of the participants’ time and energy, we had a predetermined time frame for the
interviews. Additionally, effective planning and good time management are essential
components throughout our thesis since we had a limited timeframe for the degree project. The
interviews were therefore limited to 45 minutes. Unstructured interviews are the type of
interview that is very-time consuming, while structured interviews with closed questions are
the most time effective option (Collis & Hussey, 2014, p.133), and semi-structured is therefore

31
somewhere in the middle. It is common to underestimate the time needed for an interview
(Saunders et al., 2019, p. 465). However, we considered 45 minutes to be suitable both for the
interviews and for the time needed to transcribe and analyse the data that is aligned with our
timeframe for the thesis. The interviews we conducted were all near the predetermined time
frame, however some interviews were short-lived and some exceeded.

To adhere to the semi-structure of our interviews, we based them on an interview guide, where
we had questions and themes prepared before the interview began (Collis and Hussey, 2014,
p.133). All interviews had the same structure. Our questions were forwarded to the participants
in advance for them to process the questions, making them more prepared, which hopefully
contributed to more thoughtful and developed answers. Our open-end question enabled the
participants to produce full answers, since they required a longer, developed answer (Collis &
Hussey, 2014, p. 133). However, the interviewer is responsible for being involved and
encouraging during the interview and by observant participation from the interviewer one can
become more integrated with the respondent (Bell et al., 2019, p.475; Collis & Hussey, 2014,
p. 133). Asking questions in return mad the participants elaborate their answer and was crucial
to gain insights (Collis & Hussey, 2014, p.135). Still there was a chance of interrupting the
participants when doing so, therefore the interviewer needs to manage the situation gently
(Saunders et al., 2019, p. 466) which we took into consideration. The importance lies within
having a balance between the questions, the themes and at the same time receiving advanced
questions that contributed to an insightful data analysis (Saunders et al., 2019, p. 466).

The interviews began by informing the respondents about our research ethics, including how
we will handle their information and that their identity remains confidential throughout and
after the study. We also asked our respondents if they consented to the interview being
recorded, in order to ease the transcription of the interviews later. Additionally, each participant
had received and signed a consent form going in detail regarding the research ethics. Still, the
participants had the right to withdraw and/or decline to answer a particular question (Saunders
et al., 2019, p.268). The interview guide helped us stay on the relevant topics of the interview
and ensured that the predetermined duration of the interview was maintained to a reasonable
extent. In the end, all the participants were asked whether they had anything they wanted to
add, since according to Solarino & Aguinis (2021, p.663) this can lead to additional relevant
information and deepen the insights.

4.1.3 Interview guide

The semi-structured interviews that have been carried out were based on our interview guide.
The interview guide consists of different themes, in total seven main themes and three sub-
themes, all related to our research question, see table 3. As soon as the themes were
accomplished, we continued with constructing the questions to each theme with the research
question, the theoretical framework, and the purpose in consideration. The balance to keep in
mind for the researcher is to formulate simple and short questions that are not leading but still
provide enough data to answer the research question (Bell et al., 2019, p.440 & 441).

32
Table 3: Themes in the interview guide

Introduction

Background/ Personal Experience

Pharmaceutical industry

Pharmaceutical project management

During covid-19

Risk identification

Risk identification techniques

Classification of risks

Experience

Contextualising

The interview guide comes in two different versions which can be seen in appendix six and
seven, one in English and one in Swedish, to be able to conduct the interviews in the best
possible way, in a language both parties master the most. This will prevent the chance of
translation problems or similar issues when facing a language barrier (Bell et al., 2019, p.70).
Since both researchers and the respondents had Swedish as a mother tongue, the interviews
were conducted in Swedish, which enabled us to collect more insightful and richer data.
Nevertheless, if any of the participants prefer English when conducting the interviews, the
researchers were flexible to change. This is done because the researcher tried to use the
language that is comprehensible and relevant for the participants (Bell et al., 2019, p.440).

Considering that each participant was encountered with the same questions, each interview had
the same structure and began with an introduction addressing the purpose with the study,
introducing the researchers and the rights each participant has. The intention with the
introduction is to prepare the respondent for the interview and create a pleasant atmosphere, in
order to gain trust. The first few minutes can have a great impact on the rest of the interview;
therefore, it is the researcher's responsibility to shape the start in the best way possible
(Saunders et al., 2019, p.456). By mentioning the respondents' rights before the interview and
assuring their confidentiality they should become more relaxed and open about the data they
can provide for us (Saunders et al., 2019, p.456). Following the introduction were questions
connected to the different themes. First and foremost, the interview contained background
questions to be able to contextualise the respondents following provided data. Thereafter all
questions included in our interview guide were asked. Altogether, the questions were asked
openly and neutrally to avoid bias or any confusion (Saunders et al., 2019, p.457). A non-bias
approach to asking questions will allow the respondents to formulate answers that are based on
their reality of the phenomenon and describe environments or processes as they wish, which is
an essential component in order to conduct successful semi-structured interviews (Saunders et
al., 2019, p. 458-459). Throughout each interview, the respondents were continuously asked

33
short follow-up questions to evolve their answers and deepen the data. At the latter part of the
interview, probing and specific questions were asked. The intention was to encourage more
exploration in specific areas (Saunders et al., 2019, p.459). At the end of the interview,
participants were first asked a summarising question, followed by a question regarding if they
had anything additional data they would like to provide. Giving the interviewee a moment to
reflect on the interview and an opportunity to give their opinion about risk identification in the
pharmaceutical industry.

4.1.4 Recording and transcription

We decided to record the interviews, which was done by recording the audio of the interview.
Recording the audio makes interviewers more attentive of what is being said during the
interview, giving us the possibility to follow-up on any uncertainties or interesting
observations. Recording also minimises the chance of the interviewers being distracted with
taking notes (Bell et al., 2019, p.478). The recordings were only done once the respondents had
been informed about our research ethics, how we will handle their information and once they
consented to us recording the interviews.

However, if the respondents did not consent to the recording of audio, we would be prepared
to take notes and gather information as much as we could. We also took some notes during the
interviews even if we recorded them, in order to ask appropriate probing questions and to note
if we wanted to proceed into a different question after the current one. The audio recordings
were done on our mobile phones as well as on zoom, and two devices were used throughout all
the interviews to avoid technical difficulties resulting in losing audio recordings.

To make the respondents more comfortable with the recording once they had consented, we
reminded them that they will remain anonymous along with their company name, meaning that
the interviewers are the only ones who will know that they are the source behind this specific
information. Anonymity has been highlighted throughout our contact with the respondents so
that we know for certain that they have been aware of and comfortable with the structure and
conditions of the interview. However, this does not fully eliminate the hesitation some
respondents might feel (Bell et al., 2019, p.445), but we believe that the steps we have taken to
mitigate this have been successful

Once the interviews were recorded, we chose to transcribe the audio into text. This was done
by first using a transcription tool, which transcript the audio recording. This was done to save
time. Then, we went through the recordings and the text to make any necessary amendments
to make sure that the audio and the text were identical. The transcriptions were ultimately done
to be able to use grounded theory to analyse the data we have collected. They were used to
conduct our data analysis, which is the foundation of our ability to be able to potentially answer
our research question.

34
4.2 Data analysis
Analysing qualitative data can be problematic but the key is to have a method (Saunders et al.,
2019, p.637). If we are not reflexive and explicit about how our analytical process has
proceeded which eventually generates theoretical insights, transparency in how we analyse data
cannot be provided (Grodal et al., 2020, p.591).

Since the aim of our project degree is to formulate theories based on what has been observed
in reality instead of testing theories in reality, the chosen method for analysing the data when
collected is grounded theory. The grounded theory assumes that one should break down the
collected data one has, to identify the key components (Collis & Hussey, 2014, p. 577). The
process involves analytically applying specific types of codes to the data, which is done through
a series of coding cycles that in the end leads to a theory. Therefore, the theory that is developed
is “grounded” or highly rooted in the original data (Saldaña, 2013, p.51).

For the content analysis, there are two alternative approaches, inductive and deductive (Elo &
Kyngäs, 2008, p. 109). The inductive approach is more suitable to our purpose than the
deductive, since we aspire to generate new theoretical insights and gain a deeper understanding
on how pharmaceutical projects have managed to identify risk during the Covid-19 pandemic.
Therefore, the inductive approach is adopted to our content analysis, where we will go from
the particular to the general.

Since researchers rarely get the coding right the first time (Saldaña, 2013, p. 10), the coding
process has been implemented several times. Additionally, the coding-process has been
conducted separately between the researchers, to gain perspectives on the data collected. This,
combined with a repetitive coding process, we aspire to increase our reliability in the data. As
we have coded and recoded, we have strived for our codes and categories to become more
refined and more conceptual and abstract, therefore creating a more solid foundation for the
theory building (Saldaña, 2013, p. 11). Additionally, the coding-process has been conducted
separately between the researchers, to gain perspectives on the data collected. Afterwards the
researcher compared their coding and discussed any discrepancies to comprehend each other's
interpretations of the data. This, combined with a repetitive coding process, we aspire to
increase our reliability in the data. Furthermore, the data analysis format has been inspired by
Evansluong (2016), which includes the four different steps presented in the following section.

Step 1. Developing initial codes

Our first step in developing concepts and eventually a theory, is to create initial codes by
analysing the transcribed interviews. The initial codes are “first-impressions” (Saldaña, 2013,
p.5) for the researchers. Asking questions has been a valuable tool when analysing the data
(Grodal et al., 2020, 593), enabling us to search for answers in the transcribed interviews. The
objective is to get a general overview of the data by reading through and understanding it
(Saunders, 2019, p. 205). This step generated a total of 430 initial codes across the eight
different interviews, which can be seen in table 4, below.

35
Table 4: Overview of initial codes

Case Role of Duration of Pages Number of Percentage

respondent interview transcribed initial codes of total codes

Interview 1 Project 38 min 9 pages 50 codes 11,62 %

manager
phase 1

Interview 2 Project 39 min 10 pages 52 codes 12,09 %

manager
phase 2

Interview 3 Project 43 min 9 pages 48 codes 11,16 %

manager
phase 2

Interview 4 Project 27 min 11 pages 47 codes 10,93 %

manager
phase 2

Interview 5 Medical 39 min 9 pages 45 codes 10,46 %

director

Interview 6 Scientific 56 min 13 pages 70 codes 16,27 %

officer

Interview 7 Regulatory 52 min 12 pages 62 codes 14,41 %

affairs
director

Interview 8 Project 47 min 11 pages 56 codes 13,02 %

manager
phase 2

Total 85 pages 430 100 %

Step 2. Developing first-order codes

Secondly, aligned with Bell et al. (2019, p. 528) key concepts, we conducted a first-order
analysis to generate first-order codes. The process included an analysis of the initial codes
across all interviews, to distinguish similar topics that the researcher found interesting
concerning risk identification in the pharmaceutical industry. The core of the process of
qualitative analysis is to generate categories that can form the foundation for new theoretical
insights (Grodal, 2020, p.594). Through coding we can organise our data into categories
because they share similar characteristics (Saldaña, 2013, p. 9). Similar components, elements
or quotes were therefore assembled into a first-order code, creating categories. To avoid
misrepresentation, and to stay true to the real-life context of the data collected from the
interviews, the data extracted from the interviews was always used in the appropriate context
and quoted as it was spoken by the respondents. Developing first-order codes is the first step
of going from the specific to more general findings (Grodal, 2020, p.594). As a result, the first-

36
order codes were created. In total we identified twelve first-order codes which are displayed in
table 5, below.

Table 5: Overview of first-order codes

First-order codes

1.a.1. Placing disruption by creating expertise-based allocation process

2.a.1. Developing a collection of common disruptions through previous mistakes

2.a.2. Adapting experienced techniques in unreliable surroundings based on previous projects

2.a.3 Obtaining a holistic and critical view of the project

2.b.1. Considering numerous characteristics by gathering diversified groups

2.b.2. Using brainstorming as a technique to gather several inputs

3.a.1. Approaching uncertainties continuously in a rapidly changing context

3.a.2. Making temporary decisions in an uncertain environment

3.b.1 Implementing virtual technologies to carry out routine procedures

4.a.1. Protecting the patient's safety by resource allocation

4.b.1. Handling disruptions by maintaining an open dialogue

4.b.2. Reporting continuously the project’s progress

Step 3. Developing second-order codes

Thirdly, we included existing literature in the procedure and compared it to the first order
codes. According to Eisenhardt (1989, p.544), comparing emerging concepts, theories or
hypotheses with present literature is an essential feature when building theories. We used
literature from the theoretical framework to interpret the data that had been collected. A
combination of the first-order codes and representative literature created the second-order
codes which can be found in table 6, displayed below.
Table 6: Overview of development of second-order codes

First order codes Representative literature Second-order

codes

1.a.1. Placing Risk identification consists of two tasks: (1) searching for risks and (2) 1A.
disruption by classifying the risks (Chapman & Ward, 2003, p.105). Positioning
creating expertise- uncertainties
based allocation The risk identification process is an important component of risk through
process, management which must be done well and organised in order for the structuring
project to succeed (Picciotto, 2019, p. 474). the project

Risk identification is crucial for the subsequent risk management

process (Elkington & Smallman, 2002, p.50).

Chapman (1990) and Al-Tabtabai and Diekmann (1992), both argue

that experience of a project manager does have an impact on the
identification of risks (cited in Maytorena et al. 2007, p.316).

37
2.a.1. Developing a (Larson & Gray, 2021, p.216; George, 2020, p.975; Maytorena et al., 2A. Exploring
collection of 2007, p.316). The use of brainstorming and historical data to identify previous
common risks in projects. outcomes
disruptions through individually
previous mistakes Instead of exploring and mapping out possible unknown risks, project to collect
managers tend to focus only on the most common risks they have possible
observed in the past (Hoon Kwak & Dixon, 2008, p.553). uncertainties

2.a.2. Adapting Project risk management practice has shown to be correlated with the
experienced success of meeting the project's time and budget goals (Raz et al.,
techniques in 2002, p.105).
unreliable
surroundings based
on previous
projects

2.a.3 Obtaining a People with different knowledge about different parts and stages of the
holistic and critical project are important, and so they help with creating a holistic image
view of the project of project risk (Chapman & Ward, 2003, p. 106)

2.b.1. Considering Different views on risks are necessary (Campbell, 2006, p.227). 2B. Obtaining
numerous a collective
characteristics by idea by
gathering studying
diversified groups several
perspectives

2.b.2. Using (Larson & Gray, 2021, p.216; George, 2020, p.975; Maytorena et al.,
brainstorming as a 2007, p.316). The use of brainstorming and historical data to identify
technique to gather risks in projects.
several inputs

3.a.1. Approaching Risk identification is crucial for the subsequent risk management 3A.
uncertainties process (Elkington & Smallman, 2002, p.50). It is also important to do Developing
continuously in a this early on in the project (Chapman & Ward, 2003, p. 105) an agile
rapidly changing approach to
context tackle
uncertainties

3.a.2. Making Detecting risks would benefit by input from stakeholders and is
temporary therefore something the core team should desire (Larson & Gray,
decisions in an 2021, p.212)
uncertain
environment Risk event graph (Larson & Gray, 2021, p.214)

3.b.1 Implementing The Covid-19 pandemic has impacted the industry in several ways. 3B.
virtual technologies According to Ayati et al., (2020, p.802), delays of approval, changes in Responding
to carry out routine consumptions and slowdowns. Predictability has decreased, making to change by
procedures risk identification more difficult (Maytorena et al., 2007, p.316). alternating
between
Project risk management practice has shown to be correlated with the different
success of meeting the project's time and budget goals (Raz et al., approaches
2002, p.105).

38
4.a.1. Protecting Even though Sweden is a member of the European Union and 4A.
the patients’ safety therefore takes directives from EFPIA (Zetterqvist & Mulinari, 2013, Prioritising
by resource p.2), the Swedish risk legislations is among the strictest in Europe security
allocation (Lofstedts et al., 2000, p.159). measures by
producing
effective
products

4.b.1. Handling Detecting risks would benefit by input from stakeholders and is 4B. Receiving
disruptions by therefore something the core team should desire (Larson & Gray, approval from
maintaining an 2021, p.212) authorities in
open dialogue disastrous
conditions by
following
guidelines

4.b.2. Reporting
continuously the
project’s progress

39
Step 4. Developing aggregate dimensions

Finally, we also analysed the second-order codes with representative literature, emphasising
what has already been mentioned, the importance of comparing emerging theories with present
literature (Eisenhardt, 1989, p.544). When conducting this step, the research questions were in
consideration. This, since we want to ensure that the emerging concepts and theories will be
able to answer the research question. Thereafter, we arranged and structured the concepts and
theories, combined with the literature, into a more summarised and abstracted level, creating
the aggregate dimension. Accordingly, 4 aggregated dimensions were generated which can be
seen in table 7, displayed below.
Table 7: Overview over development of aggregate dimensions

Second-order codes Representative literature Aggregate

dimension

1A. Positioning Risk identification consists of two tasks: (1) searching for risks [Link]
uncertainties through and (2) classifying the risks (Chapman & Ward, 2003, p.105). risks through
structuring the project cross-
The risk identification process is an important component of risk functionality
management which must be done well and organised in order for
the project to succeed (Picciotto, 2019, p. 474).

Risk identification is crucial for the subsequent risk management

process (Elkington & Smallman, 2002, p.50).

Chapman (1990) and Al-Tabtabai and Diekmann (1992), both

argue that experience of a project manager does have an impact
on the identification of risks (cited in Maytorena et al. 2007,
p.316).

2A. Exploring Risk identification consists of two tasks: (1) searching for risks 2. Risk search -
previous outcomes and (2) classifying the risks (Chapman & Ward, 2003, p.105). mixed approach
individually to collect
possible uncertainties Detecting risks would benefit by input from stakeholders and is
therefore something the core team should desire (Larson & Gray,
2021, p.212)

2B. Obtaining a Different views on risks are necessary (Campbell, 2006, p.227).
collective idea by
studying several People with different knowledge about different parts and stages
perspectives of the project are important (Chapman & Ward, 2003, p. 106)

(Larson & Gray, 2021, p.216; George, 2020, p.975; Maytorena

et al., 2007, p.316). The use of brainstorming and historical data
to identify risks in projects.

Project risk management practice has shown to be correlated

with the success of meeting the project's time and budget goals
(Raz et al., 2002, p.105).

Instead of exploring and mapping out possible unknown risks,

project managers tend to focus only on the most common risks
they have observed in the past (Hoon Kwak & Dixon, 2008,
p.553).

40
3A. Developing an Risk identification is crucial for the subsequent risk management 3. Reacting to
agile approach to process (Elkington & Smallman, 2002, p.50) It is also important disruptions and
tackle uncertainties to do this early on in the project (Chapman & Ward, 2003, p. complexity
105).

Detecting risks would benefit by input from stakeholders and is

therefore something the core team should desire (Larson & Gray,
2021, p.212)

Risk event graph (Larson & Gray, 2021, p.214)

3B. Responding to Project risk management practice has shown to be correlated

change by alternating with the success of meeting the project's time and budget goals
between different (Raz et al., 2002, p.105).
approaches
The Covid-19 pandemic has impacted the industry in several
ways. According to Ayati et al., (2020, p.802), delays of
approval, changes in consumptions and slowdowns.
Predictability has decreased, making risk identification more
difficult (Maytorena et al., 2007, p.316)

4A. Prioritising Even though Sweden is a member of the European Union and [Link]
security measures by therefore takes directives from EFPIA (Zetterqvist & Mulinari, external
producing effective 2013, p.2), the Swedish risk legislations is among the strictest in stakeholders to
products Europe (Lofstedts et al., 2000, p.159). accommodate
demands

4B. Receiving Detecting risks would benefit by input from stakeholders and is
approval from therefore something the core team should desire (Larson & Gray,
authorities in 2021, p.212)
disastrous conditions
by following
guidelines

41
4.3 Research ethics
Ethical principles are an important part of the research process and ensure that all participants
are treated fairly and in accordance with the vastly accepted ethical standards adhered to within
the research community (Bryman & Bell, 2017; Saunders et al, 2019; Collis & Hussey, 2014).

We have made a conscious effort throughout the research process to make sure that we adhere
to academic ethics in our research and the processing of our gathered information from the
respondents. To show how we have treated our respondents and their participation in an ethical
manner, we have used Bryman and Bell’s (2007, p.71) suggestions for ethical research
principles, shown in table 8, located below.

Table 8: Ethical research principles

Ethical principles (Bryman & Bell, 2007, p.71) The researchers’ ethical approach to research
during this study:

Harm to participants We approached the interviews with open mindsets to

The psychological and physical well-being of both the appear welcoming to our participants. The participants
researchers and the participants need to be preserved could also sit either in the comfort of their own homes,
and ensured in order to not inflict harm onto any of the or at their place of work, somewhere they are
participants acquainted with and comfortable at.

Dignity We showed our respondents respect throughout the

There needs to be respect for both the respondents’ and interviews, and we continuously affirmed their
researchers’ dignity, which will avoid causing statements to assure them that we were listening and
discomfort or anxiety for any of the participants that their information was valuable and interesting.

Privacy We did not ask any personal questions which the

The researchers need to protect the privacy of the respondents may deem uncomfortable. We also made
respondents sure that the questions were strictly related to their
professional roles.

Informed consent An information form along with a consent form were

The researchers need to ensure that the respondents’ provided to the respondents so that they were fully
consent depends on a full understanding of the ethical informed about the circumstances of the interview.
research principles which are adhered to throughout This was also done to show our respondents what was
the study expected of them and of us as researchers.

Anonymity Through the use of the consent form, the information

The researchers make it clear to the respondents that form, our other emails, and making a statement at the
their identity will not be disclosed or identifiable interview before the recording started, the respondents
through the participation of the study were informed repeatedly that their anonymity was
guaranteed throughout the course of the study.

Confidentiality This was also ensured by providing them with an

The researchers ensure the confidentiality of research information form and a consent form which they had
data for the respondents and the organisations they to sign. These forms ensured them of the
represent confidentiality which was promised by us.

Deception, Honesty, and transparency We believe that the respondents had all the
There is a chance of disruption for the research process possibilities and incentives to be honest during the
due to respondents lying or being misleading, as well interviews. However, if someone was deceiving it is
as the misrepresentation of data on behalf of the difficult for us to discover that. We trust that the
researchers. All participants involved in the research information provided to us by our respondents is their
process must exhibit honesty, trust, and openness actual perceived realities which they have recounted
to the best of their knowledge and memory.

42
 Affiliation Our research has not been sponsored. However, we
If the research is funded or sponsored, alternatively if have made it clear to our respondents about which
there are other professional affiliations, this needs to university we attend, along with our personal
be disclosed by the researchers information and the contact details to our supervisor.

Reciprocity We have had active participants throughout our

Mutual benefits for both researchers and respondents interview process, and all of them were happy to
need to be ensured throughout the research process, answer our questions. The only time they did not
and active participation and collaboration is needed answer a question, was if they did not know the
from all participants answer, or if they felt like they did not have a good
answer. We also told all our respondents that, if they
wished, we could send them the thesis once it was
finished.

Misrepresentation One way of ensuring that the data is represented

The researchers need to avoid reporting the research correctly and appropriately was transcribing the audio
findings in ways that are misleading, misrepresenting, from the interviews. We also conducted the coding of
and that may cause misunderstandings the data separately several times to ensure that the
most appropriate coding took place. By doing this, we
also minimised the risk of representing certain data
outside of their relevant context, since both authors
had to compare their coding.

4.4 Overview over practical methodology

Table 9: Overview over practical methodology

Data Collection methods Primary data through interviews

Secondary data through literature search

Sampling technique Purposeful and snowballing

Conducting the interviews Semi-structured interviews

Via video or phone calls

Research ethics Table 8. Ethical research principles

Analysis method Inductive

Grounded theory

43
5.0 Empirical findings
Within this chapter our findings from the data collection will be presented. Initially we will
present an overview of the findings. Subsequently we will present the aggregated dimensions
separately and in depth, to decompose the first order and second-order codes that the
aggregated dimensions consist of.

5.1 Findings and data structure

Our degree project objective is to provide a greater knowledge regarding how risk identification
has been conducted in pharmaceutical projects during the Covid-19 pandemic within Sweden.
The data analysis process was carried out through a grounded-theory approach, which has been
addressed in earlier chapters. Additionally, the data analysis, which was built upon three levels,
aggregate dimensions, cross-case second-order codes, and cross-case first-order codes, will be
presented further. The data structure of the analysis can be seen in figure 2, which is an
overview of how the four aggregated dimensions were produced. Therefore, we have used our
data analysis to produce a data structure that reveals the findings we will present to answer our
research question. As a result, we intend to present our result with both completeness, clarity,
and credibility, which are all important considerations when presenting the results (Zhang and
Shaw, 2012, pp.10-12).

The aggregate dimension (1) Classifying risks through cross-functionality, consists of one
component: (1A) Positioning uncertainties through structuring the project

Secondly, the aggregate dimension (2) Risk search - mixed approach is composed of two
elements: (2A) Exploring previous outcomes individually to collect possible uncertainties and
(2B) Obtaining a collective idea by studying several perspectives

Thirdly, the aggregate dimension (3) Reacting to disruptions and complexity consists of two
themes: (3A) Developing an agile approach to tackle uncertainties and (3B) Responding to
change by alternating between different approaches

Lastly, aggregate dimension (4) Considering external stakeholders to accommodate the

demands is based on two components: (4A) Prioritising security measures by producing
effective products and (4B) Receiving approval from authorities in disastrous conditions by
following guidelines

44
Figure 2: Overview of the data structure

5.2 Aggregate dimension 1: Classifying risks through cross-functionality

When pharmaceutical projects conduct risk identification, the findings implied that classifying
risks by using cross-functionality was the initial action. In order for companies to even talk
about risks, they need to have a certain structure within their organisation and know who is
responsible for which area. Therefore, they also need to collaborate between functions needed
to successfully complete the project and create cross-functionality. It then became apparent that
organising uncertainties is made through the structure of the project (1A).

1A Organising uncertainties through structuring the project

When organising uncertainties (1A), several different groups, departments, and functions
merge to orchestrate each possible disruption and its area of responsibility (1.a.1). This proved
that the structure of a project when organising uncertainties facilitates the risk identification
process, since it addresses who needs to take care of possible disruptions.

“The specialist functions get to provide their input [..] come in with their risks and then you
look at it together and you see how it affects: if there are any internal crushing functional
dependencies and things like that [..] then a person in the project team is assigned and will be
primarily responsible for monitoring the area of risk" - Respondent 1

“It is often the case that those who are under the area of responsibility find their risks
themselves and are experts in how to handle them, document it and mitigate it and also tell
others that those risks exist so that the projects know about it. [...] if it is not obvious where
they fall under the right area of responsibility, we discuss it in cross-functional meetings; how
do we do this? Or one escalates upwards in the organisation” - Respondent 7

“There are, so to speak, dependencies between the different functions and if my risks affect
others or if I have seen others' risks affect me, I am responsible for having that discussion
together with the other function representatives in our project teams.” - Respondent 2

45
5.3 Aggregate dimension 2: Searching for risks through varied approaches
When project groups search for risks within pharmaceutical projects, there is a need for
individual efforts as well as collective ones. The mixture of both individual and collective
approaches allows the project’s risk search to be more comprehensive. Thereby, exploring
previous projects’ outcome when assembling imaginable uncertainties as an individual (2A),
constitutes one half of the searching process. Furthermore, studying several perspectives during
disastrous conditions by declaring a collective idea of possible uncertainties constitutes the
other half (2B).

2A. Individually, exploring previous outcomes to collect possible uncertainties

The findings from our interviews indicated that the outcome of previous projects influence how
individuals approach uncertainties. Developing a collection of commonly occurring disruptions
through reviewing previous mistakes lays the basis for lessons learned (2.a.1.). Adapting
experienced techniques into unreliable surroundings by considering previously performed
projects to discover possible options (2.a.2.) also contributes to how individuals approach
uncertainties, especially during the Covid-19 pandemic. To be able to approach uncertainties
as an individual, project members need to obtain a holistic view of the outside world as well as
within the project by being critical to uncover weaknesses of the project (2.a.3). This shows
that within the risk identification process, tried and tested approaches are being used in
uncertain times, and there are demands on the group members when it comes to their
perspective of the project and its surroundings.

“What we do is that if it is the first time something happens, one is not aware of it. But then we
try to learn from the whole thing, and the next time we are doing the same thing, this becomes
a risk that we include in the planning stage. We then make a judgment about if it is worth taking
the risk or not.” - Respondent 2

“It’s experience. That you should have worked in many different projects and maybe different
work environments. To have experiences from different countries and cultures” - Respondent
4

“Yes, but today it is not nearly as spontaneous or detailed in the meetings. Experiences from
previous projects are very important during the pandemic. Because if someone new comes in
during the pandemic and must solve these things, it has to be very difficult” - Respondent 8

Our respondents indicated that the tools and techniques used are based on what was used before
the Covid-19 pandemic (2.a.2). Although respondent 4 indicates that there was digitalization,
the same tools were used for searching for risk.

“The normal proceedings would be to sit together with post-it notes. Everyone writes, you put
it up on the board and prioritise doing it together. It is difficult when everyone is sitting at
home, but there are tools within Teams which can be used in approximately the same way…
But otherwise, the process has been the same.” - Respondent 4

When asked about if the pandemic has affected the way risks are found and identified,
Respondent 1 indicated that the same techniques are used during the pandemic and its
subsequent unreliable surroundings as before it happened:

46
“No, not how we find them, but more that new risks have appeared that we did not see before
as a result of the pandemic… But then we have not changed our behaviour in identifying risks,
but it’s more that there are new risks.” - Respondent 1

Our respondents also indicated that it is important to obtain a holistic and critical view of the
project, both internally and externally (2.a.3).

“I think that it is important to have a holistic view on the whole thing so that you can see your
risks from a larger perspective… and then judge the risks with regard to at what point in time
the risks are considered” - Respondent 2

“To see it in its entirety, be proactive, you have to think ahead. What do we need, what are we
missing, what needs to be completed, so that we have everything we need.” - Respondent 7

“It is often the larger perspective that you need to take in. A project member is often dependant
on another project member, so it is the entirety.” - Respondent 3

“Yes, I think that to put a lot of focus into analysing the project, the surroundings, and all kinds
of things to identify possible risks early on…You look at strengths and weaknesses which
becomes the internal perspective. Then there are opportunities and threats out there” -
Respondent 1

2B. Obtaining a collective idea by studying several perspectives

2B is concerned with studying several perspectives during disastrous conditions by declare a
collective idea of possible uncertainties. How this has manifested itself under the contextual
circumstances has been described by our respondents.

Collectively, there are many factors which aid the project group in their risk search. For
example, considering numerous factors such as experience, personalities, and characteristics
by gathering diversified groups (2.b.1.) collects the group’s most preferable qualities for
dealing with uncertainties. Our data indicates that there is one type of technique which is widely
used among project teams. Using brainstorming as a technique in order to gather several inputs
on possible disruptions that could jeopardise the project (2.b.2) does this well in the
pharmaceutical industry.

“You shouldn’t have a group that sits and only thinks in the same ways. It’s important to have
people with different competences and preferably also… that there are different types of people
who are there, not just different competences. Luckily, there is often a good mix of personality
types in project groups, and it is a must to have that.” - Respondent 6

“To have a pretty diverse team is a good possible starting point, and we do since everyone
comes from different functions. So that’s one thing. Experience, absolutely…” - Respondent 8

“You want to try to have a pretty blended group so that you get different points of view. So that
everyone doesn’t think in the same way, and so that you come up with some different risks and
not only the ones you would think of yourself. You need a group where people work in some
different departments so that you get different points of view” - respondent 5

47
“Well, particularly when it comes to this with identifying risks, it is this with having a blended
group of people with different views to find the risks that do not often come up… But then with
these other risks that are a little more difficult to come up with you need the group to find them.
To think more outside of the box.” - respondent 5

Our respondents indicated that brainstorming was the main technique used in their risk
identification process when it comes to searching for risk. This also makes it possible to gather
diverse inputs from the team (2.b.2).

“We usually look at brainstorming first. Everyone just lists everything, and then we try to sort
them and group them together. Some may be quite similar…” - Respondent 4

“First we think about which risks may exist. We go around and find out, we have brainstorming
sessions.” - Respondent 5

“The brainstorming technique is something we absolutely use” - respondent 1

“Then we have brainstorming sessions where we spend time on this, so everything is allowed
and then we eventually reduce and see what the things we really can identify as the big risks”
- Respondent 8

5.4 Aggregate dimension 3: Reacting to disruptions and complexity

The findings revealed how pharmaceutical projects have a reaction towards disruptions and the
complexity of the industry which leads to changing their approach towards risk identification.
When identifying risk pharmaceutical projects have the tendency to adapt or develop an agile
approach towards uncertainties (3A) due to the unpredictable environment they are within
during the covid-19 pandemic and in general. Additionally, the findings also indicated that
pharmaceutical projects have during the covid-19 pandemic been responding to changes as a
consequence of needing to alternate between approaches (3B) and therefore identified new
risks.

3A Developing an agile approach to tackle uncertainties

Pharmaceutical projects are within an unpredictable industry; therefore, projects evolve an
agile approach to uncertainties as a way of detecting new factors or possible disruptions (3.a.1).
Furthermore, since pharmaceutical projects involve several participants and need to counter all
their demands, decisions made often need to change or be adjusted during the long lifetime a
project has (3.a.2).

In the process where pharmaceutical projects try to identify risks, most respondents addressed
how they continually, during a project, approach uncertainties (3.a.1) to detect new
considerations to take into account since the industry has been changing rapidly during the
covid-19 pandemic. Project members have experienced several times where something in the
initial parts of the projects appears sustainable and doable, but suddenly the industry changed
and the project where no longer could progress. This results in pharmaceutical projects having
the tendency to re-evaluate previously detected possible disruptions or allegations to make
remarks of any adjustments that need to be made or if they can continue without changes.

“Something looks to be good and all of a sudden it shows that we cannot deliver, due to a
factory closed again or whatever it can be, which can have horrific consequences [...] so for

48
each risk, an assessment is made that we need to follow this up within a certain time interval
or at a certain time” - Respondent 2

“You cannot do it in any simple way, to ensure all regulatory requirements and patient safety
requirements, therefore it somehow becomes more complex [...] We usually check what the
risks are before the project, then we usually have several risk assessments within the project
when, for example, we make a new product” - Respondent 5

“We have, in the beginning, a crisis plan and then we follow it up continuously during the
project [...] Sometimes you have to throw the project and re-do it if it does not go well or if a
by-product that does not exist suddenly enters the market” - Respondent 7

The last building block for 3A is how pharmaceutical projects confront several demands due
to their complex environment and therefore decisions are seldom permanent (3.a.2).
Pharmaceutical projects consist of several processes with even more involved participants, both
external and internal, and they all possess request pharmaceutical projects try to satisfy.
Therefore, when taking all the requests into consideration and confronting those demands one
decision is often modified.

“It is so incredibly complex in the pharmaceutical industry, at least in this large company there
are so many different units and different departments that must be involved and contribute their
share…” - Respondent 7

“There were far fewer choices for us (during the Covid-19 pandemic), and this applied
globally, so it was not only our company's choices that were limited, but everyone's choices
that were limited all of a sudden. Therefore, the competition was higher, the prices went up
and you might have to contract with a higher risk without having so many facts. [...] So then
we have a risk document that keeps changing continuously.” - Respondent 2

“There are so many stakeholders involved, who give their point of view. [...] We have constant
meetings during the process where you regularly discuss what happens to the various parts,
linked to risk. [...] I think the case is that you set, like, the frame itself, in the beginning, then
you work with the various sub-risks, quite continuously during the project.”
- Respondent 1

3B Responding to change by alternating between different approaches

Despite the previously mentioned procedures of developing an agile approach towards
uncertainties, pharmaceutical projects have also, during covid-19 pandemic, respond to
changes in order to alternate between different approaches (3B). Mainly these responses have
consisted of replacing physical presence to social distancing and therefore creating innovative
methods for the projects routing procedures (3.b.1).

Due to the covid-19 pandemic many project members experienced how innovative they had to
be to be able to proceed their work. The simplest task was no longer feasible since many did
not have the right equipment at home or social distance got in the way to ensure patient safety.
Therefore, during the covid-19 pandemic pharmaceutical project had to identify risks through
alternative ways and also found new risks within that.

“Everyone started working from home, we met a lot like this, digitally. Not only internally but
also towards our customers, or our doctors with whom we have contact. So, we needed to

49
change the educations we do quite quickly, instead of having them physically, have them
digitally. [...] We also got to be a little innovative in how we can ensure that patients receive
study-drugs and get their check-ups. So, we always had to be very innovative in finding new
ways to solve the situation we had” - Respondent 2

“Before the pandemic, we sat in Webex meetings, you hardly knew who was in the meetings,
you heard someone talking in the background. Now you have a massive control, you can watch
and talk at the same time. It feels like digital development has taken 20 years forward within 2
years. [...] Of course there is a risk of missing something, that communication will suffer.
Before, you sat in a room and could meet and talk, talk a little at the Coffee Machine, where
you solve a lot of problems. It's not so spontaneous anymore, so I think covid and this working
from home have made it a little more "blockish" in some way, it does not flow as well.”
- Respondent 1

5.5 Aggregate dimension 4: Considering external stakeholders to

accommodate demands
The importance of external stakeholders and their relationship with pharmaceutical projects
has been clearly indicated by our data collected from the interviews. Prioritising security
measures through distributing effective pharmaceuticals (4A) has been highlighted by many of
our respondents. Also, receiving approval from regulatory authorities by following stated
guidelines during disastrous conditions (4B) is something which has been highlighted during
the Covid-19 pandemic.

4A. Prioritising security measures by producing effective pharmaceuticals

The safety of the patients is something which is of paramount importance to pharmaceutical
projects and their members. Therefore, protecting the patients’ safety by allocating resources
to sustain the project's objectives (4.a.1) is an important part within all pharmaceutical projects.

Our respondents have recounted the patient focus as an overarching objective for the
pharmaceutical industry and projects.

“We continually focus on the patients. What we do has a purpose to serve the patients. And our
purpose with the company is really to ensure that the right patient receives the right
pharmaceutical product or medicine at the right time” - Respondent 3

When referring to the development of the vaccine development during the pandemic,
Respondent 3 exemplified how patient safety is something which cannot be tampered with in
the pharmaceutical industry:

“One can think that it went too quickly, and that the safety aspect was compromised but that
was not the case at all. It happened exactly according to how we develop all other
pharmaceuticals.” - Respondent 3

4B. Receiving approval from authorities in disastrous conditions by following guidelines

To receive approval from regulatory authorities by following stated guidelines during

disastrous conditions, pharmaceutical projects need to live up to the standards and requirements
of the pharmaceutical authorities and maintain a good relationship with them. This is done
through handling possible disturbances appropriately by maintaining an open dialogue (4.b.1.)

50
and by continuously reporting on how the project is progressing (4.b.2.).

The respondents of this study have reflected on their communications with regulatory
authorities. They have indicated that maintaining an open dialogue is an appropriate and
effective way of handling disturbances (4.b.1).

“We must adhere to them. That is the way we organise our programs. And then we have
interactions with authorities. We had an interaction with Läkemedelsverket in Sweden at the
end of March where we asked some questions just to, yeah just to really ensure that we are not
missing anything for the next step. In this case we had changed the process for the molecule
that we use and then we have to ensure that it is okay to use.” - Respondent 4

“Well, we mainly communicate with FDA and EMA, and they are both high quality authorities
who come with a lot of good input. Also, luckily, it is possible to have discussions with them
about their opinions and ideas. But they are also good when it comes to input from their point
of view, with many good comments which makes us furrow our brows and really consider what
we need to think about in different ways. They provide us with valuable input, but they also
provide input which is open for discussion” - Respondent 6

Furthermore, our respondents have also recounted how they continuously must report the
progress of the project (4.b.2) to the regulatory authorities as a part of following the conditions
of the guidelines and regulations that they operate under.

“Then we also have to submit to the authorities everything we have found. Eventual side-effects
and things like that… So, if something comes up, we see it and then we have to report it to the
authorities so that they know everything that we know. So, there are very well-established
processes for how we go about things, and there are very strict demands from the authorities
that everything is reported on time.” - Respondent 7

“When you send in an application to be able to sell a product, you have a risk management
plan which is included in the application. Within that you have gone through everything…In
our case it has to be sent to the authority and be approved, and for every thing that is added,
it must be updated and sent to the authority again. So even if you have a big application which
goes in, it is possible that you have to send only that (risk management plan) with what has
been added.” - Respondent 7

51
6.0 Discussion and Theory Elaboration
In this chapter we have attempted a more thorough analysis of findings presented previously.
The chapter consists of separate discussions of each aggregate dimension and compares them
to the existing literature, which shows both similarities and differences. Furthermore, the
discussions combined will then contribute to a theory elaboration. With the theory elaboration
we will present a proposed model to answer the research questions of this thesis, of how
companies conduct risk identification within pharmaceutical projects during the covid-19
pandemic in Sweden.

6.1 Classifying risks through cross-functionality

In contrast to existing literature, our results indicated that risk classification is the first step for
drug projects when risk is identified. According to Chapman & Ward (2003, p.105), risk
identification consists of two tasks: (1) searching for risks and (2) classifying the risks. Our
findings instead indicate that risk identification first classifies the risk and who is responsible
for the area that the risk belongs to. Thereafter the search for risks begins. e.g., a project
member is responsible for searching for the risk in their area. For example, toxicological risks.

Nevertheless, the findings also agree with existing literature that highlights the importance of
risk identification (Picciotto, 2019, p. 474; Elkington & Smallman, 2002, p.50). Even if the
findings change the rotation scheme between classifying and searching, the significance is still
the same, according to our findings. According to Picciotto (2019, p.474) risk identification is
a component that holds a project's success in its hands. It must be done well and organised for
the project to succeed. Our findings rather suggest that the classification of risk is something
solely relying on the structure of the organisation and project. Within the structure, each
member of the project is given great personal responsibility. If the structure is distinct, the
classification of risk will be obvious.

Why the member is given the large responsibility within their function in the project mainly
allocates to their large amount of expertise and knowledge. Our interview uncovered how each
member often holds a high education and a lifetime of experience within the pharmaceutical
industry. Therefore, the organisation is often comfortable giving project members the task and
responsibility to identify risks themselves. Due to this, the allocation process for how to classify
the risk is self-acting and hard for project members to pinpoint. Therefore, our findings agree
with Chapman (1990) and Al-Tabtabai and Diekmann (1992), who both argue that experience
has an impact on the identification of risks (cited in Maytorena et al. 2007, p.316). However,
it should not be interpreted as meaning that the classification is not sufficient. Pharmaceutical
projects instead have such well-organised structure that facilitates the search for risk.

6.2. Searching for risks through varied approaches

Based on our findings, searching for risks within pharmaceutical projects in the risk
management process consists of two approaches which are complements to each other. These
are the individual and the collective approaches. Initially approaching the process of risk
searching is mostly done on an individual level. This is where project members’ previous
experiences and projects allow for a personal collection of common disruptions can be created,
as supported by (Hoon Kwak & Dixon, 2008, p.553). This collection then lays the basis for a
comprehensive and well-rounded risk search on an individual level within the member’s

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specific area of expertise. Expertise comes from both the group members’ educations, as well
as their relevant practical experiences.

Within the literature related to risk identification and experience, there is a lack of consensus
as to whether experience has an influence on the quality of the risk identification process.
However, our findings indicate that experience does significantly influence the ability to find
possible and probable risks according to practising project members, which is consistent with
the arguments of Brown & Grundy (2016, p.192), as well as Chapman (1990) and Al-Tabtabai
and Diekmann (1992) (cited in Maytorena et al. 2007, p.316). Our respondents have indicated
that previous experiences lay the foundation for how one approaches new projects, and that
risks often are transferable from old projects to new projects within the same area. This is also
aided by the previously mentioned classifying of risks, as project members often approach risk
searching on an individual level almost solely within the area connected to their function within
the project.

As stated, transferability becomes possible if the project members and project managers have
previous experience. However, our respondents have also indicated that even in unreliable
surroundings such as the Covid-19 pandemic, experience is also a virtue when it comes to being
able to identify risks for the project they are currently working on. An interesting finding from
our data is that project members and project managers often find it difficult to specifically and
explicitly explain how they go about finding risks. For them, it often ‘just happens’. This is, to
us, a further indication of the importance of experience for successful and comprehensive risk
searches.

Something which has been discovered through our interviews, is that having a holistic view of
the project is something which project members deem as a beneficial perspective. This can be
related to Kaplan (2008, p.729), and the presence of cognitive frames during ambiguous
situations. Seeing both the project and the external environment in their entirety means that
project members are more likely to include a larger range of possible disturbances,
uncertainties, or risks.

This holistic view needs to be complemented with a critical view, which our respondents have
indicated to give project members a better opportunity to become aware of weaknesses or risks.
Having a critical view can almost be considered synonymous with a realistic view in the case
of pharmaceutical projects. Our respondents have indicated that somewhere around 90% of
pharmaceutical projects fail before they are able to sell a product. This is because of the
countless obstacles pharmaceutical projects face during their lifespan. This means that
experienced project members likely are aware of and almost expect the project to be
unsuccessful. Existing literature mentions the existence and influence which a critical view can
have on handling risks. Larson & Gray (2021, p.219) argue that it can be difficult and
paradoxical to be optimistic about the prospects of the project, while simultaneously having a
critical view on the project to be able to find risks.

Once risk search has been conducted on an individual level, the project team gathers and
collectively conducts a risk search. Gathering the project team means that people with different
experiences, personalities, and characteristics come together to utilise numerous perspectives
on the possible risks that may come up during the life span of the project. Almost all our
respondents mentioned brainstorming as the technique they use in their risk search. If a
respondent did not use the specific phrase ‘brainstorming’, they most often indicated in other
words that this is the technique used by the team. Using brainstorming within a diverse group

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facilitates the creation of a collective idea of the relevant risks for the project. This argument
is also made by Larson & Gray (2021, p.216) and George (2020, p.975).

6.3 Reacting to disruptions and complexity

Our third aggregated dimension, established from our interview, demonstrated that the
companies in charge of the pharmaceutical projects had during the covid-19 pandemic been
forced to change their approach when conducting routine procedures. Mainly because of the
restrictions. Further, the covid-19 pandemic impacted the industry with delays and slow-downs
which is coherent with current literature that also highlights the consequences of the pandemic
(Maytorena et al., 2007, p.316). The unpredictability of the pandemic has caused the urge to
obtain innovative solutions that can alternate between conditions. So, when restrictions are
tightened, pharmaceutical projects can proceed without change since they have techniques and
tools that are hybrid.

When an unpredictable disruption appears, our findings show that it causes a reaction to either
(1) decide to continue and therefore establish a temporary completed risk identification or (2)
re-consider the identification of risk and investigate if the unpredictable disruption has changed
the previous perception of which risks the project has. Depending on the disruption, it could
either not change the fact that the project must proceed as planned or the disruptions caused
things to change, i.e., delivery-delays which then made them miss the deadline which had
greater consequences. Therefore, each disruption during the pandemic must be handled
separately due to its complex environment. No two disruptions are alike. Pharmaceutical
projects have therefore developed an agile approach which could accommodate for the danger
of a risk occurring late in the project and causing threatening consequences to the project,
according to the risk event graph (Larson & Gray, 2021, p.214).

The second option results in a pharmaceutical project conducting a re-assessment of the risks.
Our respondents showed that they are familiar with developing innovative solutions that can
function as a hybrid and alternate between conditions. However, the pandemic has highlighted
the necessity of an agile approach towards risk. Since the predictability has decreased, which
makes risk identification more difficult (Maytorena et al., 2007, p.316), project members have
seen the agile approach as the solution. Our findings indicated that the frame and the foundation
of risk identification is made in early stages, which is favourable according to Chapman &
Ward (2003, p. 105). Thereafter if a disruption appears, a re-assessment can be made, if not a
temporary completed risk identification is established. Additionally, what our findings
discovered is that no risk identification can ever be permanently established due to the complex
environment. Not only do pharmaceutical projects have several participants involved within
the project, which has shown to benefit risk identification when stakeholder get involved,
similar to Larson & Gray (2021, p.212). Moreover, the project usually proceeds over a longer
period. Some of our respondents had experienced projects that lasted over fifteen years. This
results in that decisions can rarely be permanent. Thus, decisions about what risks exist cannot
be everlasting either. Therefore, projects have the tendency to re-evaluate the risk identification
within a certain time interval or at a certain time, creating an agile approach to risk
identification.

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6.4 Considering external stakeholders to accommodate demands
Our fourth and final aggregate dimension distilled from our data relates to how the project and
its members maintain the relationship with their external stakeholders. Primarily, the purpose
of the pharmaceutical industry is to provide patients with pharmaceutical products to improve
their health, and this is also mentioned as the project objective by many of our respondents.
They all mention patient safety as a crucial factor within their industry. This can be related to
two of the major characteristics of a project, having an established objective, and there being
special requirements pertaining to time, cost, and performance (Larson & Gray, 2021, p.7).
The performance is especially important when relating pharmaceutical projects to the external
stakeholders, both in the sense of effectiveness of the product for the patients’ sake, and also
living up to the regulatory standards set by authorities.

Our respondents have indicated that the importance of their relationship with regulatory
authorities cannot be overstated. They rely on authorities constantly throughout the risk
management process, and the authorities give pharmaceutical projects a framework to adhere
to. This makes it easier for project members and project managers to know how to approach
uncertainties and risk. Larson & Gray (2021, p.212) argue that input from stakeholders is
beneficial and can be seen as a tool in the risk identification process, and this is also confirmed
to be true in practice by our respondents.

As Lofstedts et al (2000, p.159) mention, within Europe, the Swedish risk legislations is one
of the strictest. This strict legislation paired with the need for input from stakeholders which
previous literature suggests, further indicates the importance of the relationship with regulatory
authorities. Furthermore, along with the very complex environment that exists within the
pharmaceutical industry, our respondents have indicated that a continuous dialogue with
stakeholders, and especially with regulatory authorities is crucial to the survival or success of
the project. Being able to have an open and continuous discussion with authorities about
specifics within pharmaceutical projects means that hurdles and challenges can be overcome
faster and with greater ease. This continuous dialogue is also something which is encouraged,
and at times, demanded by the authorities. For example, if a new risk is identified, this must be
reported to the authorities as they always demand all the information available about the
project.

6.5 Process model for risk identification during the covid-19 pandemic in
pharmaceutical projects
These discussion points can be combined and facilitate an elaboration of a model. A common
criticism towards the inductive approach is that the theorising, or the mode elaboration has not
started close enough to the phenomenon (Shepherd & Sutcliffe, 2011, p. 363). Since our model,
of how pharmaceutical projects perform their risk identification during covid-19, contained a
thoughtful data analysis with grounded theory approach we therefore argue that we have
created a model and theory as close to the data as possible. Additionally, when developing our
model, see figure 3 of how pharmaceutical projects conduct risk identification we have
considered four essential elements: What, How, Why and Description and explanation
(Whetten, 1989, p.490-491). ‘What’ represents which factors are included in the model.
According to Whetten, (1989, p.490), the challenge here is to find the right balance by
including relevant factors and excluding factors that add little value to understand the model.
‘How’ portrays the relationship between the factors. In our model we have established this
element by inserted arrows to connect each factor that is included in risk identification.

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Additionally, we contextualised the arrows to clarify our thinking and increase the readers
comprehension of our model. The third element ‘Why’, represents the underlying
psychological, economic, or social dynamics that justify the selection of factors and the
proposed causal relationships (Whetten, 1989, p.491). In line with our degree project, the
covid-19 pandemic has been the underlying component, which also became prominent when
developing the model. What, how and why combined facilitates the last element; description
and explanation (Whetten, 1989, p.491). Altogether we have developed a model including
descriptions to explain the model and therefore developed a model that expectantly should be
comprehensible for readers.

We have, during the elaboration of the model, identified multiple factors that are essential in
order to identify risks in pharmaceutical projects during the covid-19 pandemic. The elaborated
model is based upon both aggregated dimensions, second-order codes, and the discussions that
we carried out in the previous sections. This model will present both how pharmaceutical
projects conduct risk identification the ordinary way during covid-19 pandemic and the
exceptional case when unpredictable disruptions appear, and stakeholders govern the risk
identification.

Figure 3: Process model for risk identification during the covid-19 pandemic in pharmaceutical projects

The beginning for identifying risks in pharmaceutical projects starts with step 1: classifying the
risks. These were the most contradictory findings when we compared our results to existing
literature. It was evident that pharmaceutical companies have created such an obvious cross-
functional structure, that classifying risk is not something one can pinpoint to an event or
action. The core of this is the project members’ expertise and knowledge within their area of
responsibility. However, it is only possible through organisations giving the project members
trust and the responsibility needed. The classification of risk and the structure obtained in the
projects facilitated the next step of identifying risk. This, due to when the structure is set, they
know who will search within which category.

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The following stage, step 2: risk search - mixed approach consists of searching for risks.
Firstly, an individual search begins which has been mentioned and is mainly involving the
project members previous experience of projects. Afterwards each project member merges
their experiences together and conducts a collective risk search within varied groups. Here,
stakeholders such as regulatory authorities have guidelines that benefit and give guidance to
the search of risk. They may have suggestions or recommendations that can support the search
for risks. For each discovered risk, step 3: a reaction is created where the stakeholders,
especially regulatory authorities, also have a contributing part. Not only do they provide
guidance, but they also govern that the guidelines are maintained.

Additionally, due to the long lifetime a pharmaceutical project has, they experience a lot of
unpredictable disruptions during the lifetime of the project which alter the reaction of a
discovered risk. Especially during the Covid-19 pandemic, unpredictable disruptions have
appeared frequently and if the unpredictable disruptions are sufficiently extensive or
transformative, pharmaceutical projects need to reconsider their discovered risks. Either they
might need to modify which risks they prioritise the most, if anything has changed with the
already discovered risk, or if the unpredictable disruptions might have caused more risks to be
revealed. This creates an agile approach to tackle uncertainties, incentivising pharmaceutical
projects to re-assess their risk identification.

However, when an unpredictable disruption occurs that is not sufficiently extensive or

transformative to the project, it can be decided to complete the risk identification, entering the
last stage of the process model for risk identification, step 4: Temporarily completed risk
identification. This decision is also made when unpredictable disruptions are not present, and
when guidelines have been adhered to. Despite that, the process model for risk identification
during covid-19 pandemic in pharmaceutical projects is not finished. The decision of entering
the last stage is only temporary due to the long lifetime of pharmaceutical projects. Thereby,
the pharmaceutical project must re-evaluate the identified risk throughout the project for two
reasons. Either (1) they need to study and investigate if their previously identified risk is still
up to date. Otherwise, (2) they re-evaluate the risk identification to discover additional risks
that could jeopardise the project.

Our proposed model therefore suggests that the risk identification process is perpetual
throughout the lifetime of pharmaceutical projects. Identifying risks is something which
therefore needs to be continuously performed to successfully manage risk throughout the
project.

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7.0 Conclusion and contributions
In this chapter we will present a general conclusion of how we have enabled to answer our
research question and met the purpose of this degree project. In addition, we will provide the
theoretical contribution this thesis has to offer, followed by practical and societal
recommendations. Finally, limitations that this thesis has encountered combined with possible
future research area will be displayed.

7.1 Conclusion
The purpose of this degree project was to provide insights into the beginning stages of risk
management for projects during Covid-19 in Sweden, within the pharmaceutical industry,
which is of crucial importance to our society. We aspired to develop an understanding into how
risk identification has changed because of the covid-19 pandemic. Furthermore, we wished to
establish an insight that potentially leads to improved risk identification and more effective use
of techniques. Through conducting qualitative semi-structured interviews with pharmaceutical
project members that had operated in projects during the covid-19 pandemic, these
observations could be achieved. By using grounded theory approach and our coding method
we could detect how our findings correlate to the existing literature and what new
understandings could be achieved. This served as the basis for answering the research question
of this degree project being:

- How do companies conduct risk identification within pharmaceutical projects

during the covid-19 pandemic in Sweden?

Our findings imply that risk identification in pharmaceutical projects consists of four
dimensions; 1. Classifying risk through cross-functionality, 2. Risk search - mixed approach,
3. Reacting to disruptions and complexity and lastly, 4. Considering external stakeholders to
accommodate demands. Further, these dimensions with their underlying codes generated the
proposed process model seen in figure 3, which was shaped by both the findings and the current
literature. Our proposed model addresses the key building blocks of how pharmaceutical
projects have implemented risk identification during the Covid-19 pandemic and also displays
how they are connected. In addition, our model differs from current literature in the following
ways: Firstly, we detected that pharmaceutical projects classify their risk before the search of
risks begins, due to the obvious structure between cross-functional teams. Secondly, when the
search begins an individual search is carried out first which largely involves studying
previously completed projects and later a collective search is completed where brainstorming
has been the main activity that our respondents use to allocate possible disruptions. Thirdly,
when the search has been completed pharmaceutical projects need to create a decision that is
governed and altered by stakeholders and unpredictable disruptions. They can then choose to
re-assess their risk search through an agile approach or enter the last stage of the model, the
temporarily completed risk identification. Finally, since pharmaceutical projects tend to
proceed during a long period of time, our findings discovered that risk identification is a
recurring process. Therefore, after a certain period of time, projects need to re-evaluate their
identified risks and carry out the process again.

In conclusion, our results show that these four dimensions as written above represent the most
widely used approach to risk identification in pharmaceutical projects during the Covid-19
pandemic. Our conclusion is that these dimensions and their underpinning activities answer the
research question.

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7.2 Theoretical contributions
Developing new theories or significantly contributing to existing theories is a challenging feat
(Shepherd and Sutcliffe, 2011, p.361). Despite this, the research conducted, and the subsequent
results developed throughout this thesis has resulted in theoretical contributions.

This study acts as a response to the need for more knowledge about project management within
pharmaceutical projects, which is argued to be less developed than other established industries
(Chauhan & Srivastava, 2014, p.57). It also gives an insight into the risk identification process
for which there has been a lack of development when it comes to explaining how it takes place
in terms of searching and classifying.

Our study led to three theoretical contributions. First, it contributed to a new concept regarding
the current order in which activities within risk identification take place, which was originally
constructed by Chapman & Ward (2003, p.105) who stated that risk identification consists of
two activities: (1) searching for risk and (2) classifying risks. After our study, the construction
has been modified into switching order on the two activities, resulting in risk identification
consisting of (1) classifying the risk and (2) searching for risks. Due to the organisational
structure and the subsequent formation of cross-functional teams within pharmaceutical
projects, risks are already classified before the searching begins. This can be explained by
expertise within one’s specific function which means that a project member will identify risks
which pertain to their specific area or function. The expertise also facilitates how searching for
risk happens on an individual basis before the project group comes together and approaches
risk identification collectively.

Second, there are activities within our model that could be considered new for when one is
explaining risk identification. The context of the pandemic has enabled us to extend the
literature and detect the relationship between pharmaceutical projects and the external
stakeholders, especially the regulatory authorities. In our model we have included the
relationship stakeholder has to the process of identifying a risk, showing how continuous and
imperative the dialogue between pharmaceutical companies and regulatory authorities are.
Previous studies (Lofstedt et al., 2000, p.159) has indicated that the Swedish regulatory
authorities are one of the strictest, whereas our findings evolves that theory and show how
regulatory authorities not only govern but also guide pharmaceutical projects during their
development of new products. We have therefore also, at least partially, achieved the purpose
of grounded theory, which is to elicit fresh understandings about patterned relationships and
how these relationships with the interactions construct reality (Glaser & Strauss, 1967 cited in
Cornelissen, 2016, p.378). These results suggest that pharmaceutical project enhances their
chance of succeeding when maintaining a dialogue and a cooperation

Finally, our research contributes to the literature of pharmaceutical projects by examining risk
identification in the context of the Covid-19 pandemic. This provides insights of how extreme
uncertainty and unpredictable disruptions can affect a project and can be partially prevented by
incorporating appropriate risk identification. These results indicate the importance of having
experience among project members in order to identify risks. This will therefore contribute to
settle the reflection Maytorena et al. (2007, p.316) had about whether experience is a
contributing factor when it comes to conducting a comprehensive risk identification. Our
findings suggest that during the Covid-19 pandemic, experience is perhaps even more
important for risk identification than it ever was before.

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7.3 Practical recommendations
Based on our empirical findings, we provide some practical recommendations from this study
to give some insight for people who are or will be involved in pharmaceutical projects where
a risk identification process takes place. These practical recommendations may also in some
cases be applicable for others who work within complex projects in other industries.

Firstly, pharmaceutical projects and their members may benefit from being aware of the
anatomy of the risk identification process so that they can structure their time and resources in
the most efficient way. Knowing that the complex nature of the industry, and the subsequent
specialised functions within the project group affects the risk identification process is helpful,
especially for project managers. If risks already are classified when project members conduct
their risk search, project managers may find the individual search for risks relatively more
worth spending time on compared to the collective risk search. This is because from our
research, we indicate that experience and one’s area of expertise are the largest contributing
factors for finding risks. This is not to say, however, that the collective approach should be cast
aside. Our results also indicate that project managers and other project members should value
the collective search for risks, as several different characteristics and inputs are important for
conducting a thorough and comprehensive risk identification process.

Secondly, we also recommend that practitioners within pharmaceutical projects, especially

during uncertain times such as the Covid-19 pandemic, maintain a holistic view of the internal
and external environments to the project. This will allow them to find important risks which
may not be completely obvious. This will also be aided by having a critical mindset when it
comes to the project. Our recommendation is therefore to have some optimism when it comes
to the predicted success of the project, but to also keep in mind the success rates within the
industry, and by maintaining a critical view, be able to identify upcoming obstacles or
disturbances to strive for the best result.

Finally, it is our recommendation that pharmaceutical project members and project managers
consider step 3 in our model which is the reaction step, especially in complex environments
such as the Covid-19 pandemic. This suggests that when unpredictable disturbances occur in
these environments, the risk identification does not need to be completely re-done. Rather,
when disturbances occur, the risk identification process can circle back to step 2, which is the
mixed approach risk search. The disturbance, which inevitably materialises into a risk can be
tackled by this mixed approach - risk search involving the individual, but in this case, mainly
the collective approach.

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7.4 Societal recommendations
On a larger scale, we will also provide some societal implications and recommendations from
our findings regarding how companies conduct the risk identification process within
pharmaceutical projects during the Covid-19 pandemic in Sweden. This includes the
implications for relevant stakeholders as well as some of the contextual factors of this study.

It has become evident during our research that patient safety is an objective of the utmost
importance when it comes to the pharmaceutical industry. This has cemented the significance
of the risk identification process and how this is conducted within the industry. Thereby, one
of the most important stakeholders of pharmaceutical projects, the patients, can become aware
of how the risk identification process is conducted. Clinical trial participants, which fall under
the scope of patients as a group, can also receive more insight into how the products they will
use are developed and the effort that goes into the first step of the risk management process,
ensuring their well-being.

This study also has implications for the regulatory authorities within the pharmaceutical
industry. By getting further insight into how the risk identification process is conducted within
pharmaceutical projects within complex environments, this can be helpful in the understanding
of the risk documents they receive in their communication with the projects. Regulatory
authorities can also use the findings of this thesis to critically examine how pharmaceutical
projects carry out their risk identification processes. More specifically, they may be able to
provide input on the structural constellations of pharmaceutical companies and how they deem
this to have an either positive or negative effect on how risks are handled. It may also be
beneficial for regulatory authorities to be aware of the findings of this thesis for the purpose of
communicating with individual projects. For example, if they are aware of step 1 of our model,
classifying risk, they may be able to ask questions more directly. This may also mean that they
can contact the relevant functional departments, and thereby receive answers more quickly.

For the Swedish society at large, this thesis can provide insight into a part of pharmaceutical
projects and their anatomy. The pharmaceutical industry is a growing industry within Sweden
and has especially been growing during the Covid-19 pandemic (lif, 2022). The Swedish
society can gain an insight into parts of how this industry operates, and the seriousness with
which pharmaceutical companies in Sweden conduct their projects. The findings from our
thesis indicate that within Sweden, and within Europe, the very strict regulatory rules and
regulations as enforced by the regulatory authorities ensures some sense of transparency of the
industry. However, due to the high level of confidentiality, complete transparency will not be
possible. Despite this, these regulatory conditions can contribute to a sense of comfort in
knowing that there are immensely high requirements to receive approval to produce and
distribute pharmaceutical products on the Swedish and European markets. This is as true for
Covid-19 times as it is for ‘normal’ times.

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7.5 Limitations and future research
Firstly, in reference to our delimitation in this thesis, risk identification is the catalyst for a
much longer management-process, containing mitigation approaches, contingency plans and
several other procedures when carefully executing risk management. As a result, it would be
valuable to also investigate the other part of the whole risk management process and distinguish
how those procedures have been conducted during Covid-19 pandemic within pharmaceutical
projects. By assembling knowledge about all parts of risk management during the Covid-19
pandemic in pharmaceutical projects, the industry could improve their success-rate in projects,
enabling more effective products on the market and improved support for patients in need.

Secondly, as demonstrated during our degree project, the pharmaceutical industry is highly
complex. Nevertheless, there are other high-tech industries that would be interesting to
examine. We choose to focus entirely on the pharmaceutical industry, but the covid-19
pandemic has not only affected the pharmaceutical industry. Therefore, it is intriguing to
investigate if the industries differ between the consequences of the Covid-19 pandemic.
Additionally, we studied solely companies operating within Sweden, although other countries
with different regulations and regulatory authorities are an appealing perspective for future
research.

Thirdly, future research could expand into other contextual elements, such as other countries
or continents. There could also be an expansion of the research into other complex
environments as represented by other events which affect the area of study, for example wars.
Research into future events may also eventually be able to compare the results of this study
and draw conclusions on how different complex environments with different contextual factors
affect the risk identification process, or possibly the risk management process as a whole.

Lastly, during our degree project it has been revealed how the industry prioritises and cares for
their stakeholders such as patients and regulatory authorities, while also emphasising the
importance of obtaining a holistic view when proceeding with pharmaceutical projects. In the
spirit of a holistic view, acquiring the stakeholders’ perspective on how risk identification is
conducted in pharmaceutical projects could be beneficial to gain more perspective. Therefore,
also improving their risk identification by letting future research collect the stakeholders’
perspective.

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8.0 Quality criteria
Within research, it is essential to provide and maintain quality, meaning truthful findings that
are in line with reality. To preserve quality, we will present two criteria we have included in
our degree project. Normally, validity and reliability are the most common criteria used to
evaluate the research (Collis & Hussey, 2014, p.52-54; Saunders et al., 2009, p. 157-158).
However, these criteria can seem inapplicable and inappropriate to use to qualitative studies
and suits quantitative studies better (Bell et al., 2019, p.48). Therefore, we have instead applied
Trustworthiness and Authenticity as the two criteria which will assess the quality of our thesis
(Bell et al., 2019, p.48). Trustworthiness is a criterion which consists of four components:
Credibility, Transferability, Dependability and Confirmability. Whereas authenticity content
by five components; Fairness, Ontological authenticity, Educative authenticity, Catalytic
authenticity, and Tactical authenticity (Amin, 2020, p.8-10). In addition, qualitative studies
have the tendency to not be as generalisable as quantitative studies (Collis & Hussey, 2014,
p.54). Therefore, we will present in accordance with how the authors have placed their study
in correlation with the two selected primary quality criteria, which contributes to increased
transparency.

8.1 Trustworthiness
Credibility
Starting with credibility within trustworthiness which refers to the truth of the data, or the
participants' views and the interpretation and representation of them (Cope, 2014, p.89). In
other words, how believable are the findings? This can be compared to internal validity for
quantitative studies (Bell et al., 2019, p.48; Korstjens and Moser, 2017, p.121). To ensure
credibility we have used a prolonged engagement, meaning that we have spent adequate time
with both the respondents and within the research area to learn about the culture, build trust
and have time to reflect on potential flaws with the areas of research (Amin et al., 2020, p.2).
In addition to prolonged engagement, we have also adopted persistent observation during our
research to identify characteristics and elements that are most relevant for our question and
issue (Amin et al., 2020, p.3). According to Amin et al. (2020, p.3), prolonged engagement
provides scope while persistent observation provides a depth to our research.

Firstly, for the prolonged engagement we provided anonymity to establish a comfortable

environment to the respondents. To increase this further, we had a duration of the interviews
which allowed respondents to reason with themselves and elaborate their thoughts and
experiences by giving examples. When conducting the interviews, we asked follow-up
questions to investigate any captivating emerging topic that the respondents might bring up.

Secondly, to ensure credibility, one can see through our practical methodology how we
conducted a coding process which reflects upon a persistent observation. We systematically
processed the data combined with theories to elaborate codes that developed a model to answer
our research question. The data was repeatedly reviewed to create as authentic coding as
possible.

Thirdly, we included investigator triangulation (Amin, 2020, p.5). Investigator triangulation

means that several researchers are involved when analysing the data using the same technique.
Several researchers with the same techniques should reach the same results. However, the
reality is not always the same. If the researchers encountered any disagreement of how the data

63
was interpreted, we discussed the differences and then found common ground for a new
interpretation that was better suited.

Transferability
The second criterion within trustworthiness is transferability which refers to how findings can
be applied to other settings or groups (Cope, 2014, p.89). In other words, do the findings apply
to other contexts? Transferability to qualitative studies can be parallels for external validity in
quantitative studies and can therefore also be referred to as generalisability (Bell et al., 2019,
p.48). It is important to include transferability, since it is the reader who decides whether the
findings are generalisability or not (Cope, 2014, p.89). Therefore, the author should provide
sufficient information on the informants and the research context to accredit the reader to
evaluate if the findings are transferable (Cope, 2014, p.89). This criterion will therefore be met
if the results have meaning to individuals who are not involved in the study and they can
associate the result to their own experiences (Cope, 2014, p.89).

Our findings are mainly rooted in the disruption of the society relative to the Covid-10
pandemic. Therefore, our findings might not be generalizable to all scenarios. However, it can
be transferable to common settings where complexity and uncertainty is arising. Additionally,
since we have gathered data from a high-tech industry the result might be suitable for a broader
perspective and several industries, intriguing more individuals to perceive our findings
meaningful.

Dependability
Thirdly, the dependability criteria refer to the constancy of data under similar conditions (Cope,
2014, p.89). In other words, are the findings likely to apply at other times? In quantitative
studies dependability can be paralleled to reliability (Bell et al., 2019, p.48). Dependability is
achieved when another researcher conducts a study with similar characteristics and arrives at
similar conclusions, or at least agrees with the conclusions that first researchers stated (Cope,
2014, p.89). Within our thesis, we can make sure to define and present our research process
clearly, so that a reader can easily follow the decisions made by us. To meet this criterion, we
have strived to be as transparent with our decision and the process to the highest degree
possible, both through the theoretical standpoints and the practical methodology. Concluded,
the reader can easily detect how our study was executed and what stands behind the choices
we made.

Confirmability
The last criterion within trustworthiness is confirmability. Confirmability refers to the
researcher's ability to illustrate that the data represent the participants´ answers and not the
researcher's biases or viewpoints (Cope, 2014, p.89). The question to be asked is; Has the
investigator allowed his or her values to intrude to a high degree? Confirmability can be seen
as the criteria of objectivity for quantitative studies (Bell et al., 2019, p.48). To establish
objectivity of confirmability to a high degree, we have chosen to display our coding process,
leading up to the aggregate dimension thoroughly. However, it can be difficult to ensure entire
detachments of one's personal values in business research (Bell et al., 2019, p. 375). To
minimise the personal values that interfere with the data, we have ensured that both researchers
have been participating during the data collection and the analysis, to enable a dialogue when
interpreting the respondents’ answers.

64
8.2 Authenticity
Fairness

Firstly, we will discuss the fairness criteria which falls under authenticity. Fairness has to do
with if the research is representative of the respondents’ different experienced realities have
been taken into account when recounting the responses from the conducted interviews (Amin
et al., 2020, p.8). With regard to fairness, all our respondents have been a part of the risk
identification process during the Covid-19 pandemic. This was used as a criterion for being
able to act as a respondent for the study. For a fair characterisation of the risk identification
process, project members of different hierarchical levels and positions within pharmaceutical
projects were interviewed. This gave us the opportunity to approach the risk identification
process from several lived realities of our respondents. For this reason, it is our opinion that
the fairness in this study is high. Furthermore, we only interviewed respondents who had
operated under the same contextual circumstances when it came to the pharmaceutical industry
in Sweden during the Covid-19 pandemic, to enhance the fairness of our research.

Ontological authenticity

The ontological authenticity relates to how the study has been able to aid parties involved in
gaining a deeper understanding of the relevant social setting (Amin et al., 2020, p.9). This study
contributes to the understanding of the risk identification within pharmaceutical projects during
Covid-19 in Sweden by the model we have developed of the risk identification process. This
means that one can gain a deeper understanding of the beginning of the risk management
process within pharmaceutical projects. It also means that the organisational influences such
as the cross-functional teams and the significance this plays in risk identification within
pharmaceutical projects can become clearer. Hence, this study contributes to both practitioners'
and researchers’ understanding of the social setting.

Educative authenticity

The educative authenticity concerns how the participants of the study have an enhanced
awareness and understanding of those outside of their own stakeholder group (Amin et al.,
2020, p.9). We deem this criterion to be met, as the respondents in this study have continuously
reflected upon the different stakeholders of pharmaceutical projects. There have been elaborate
recounts of their relationships with these stakeholders, and the respondents have regularly
presented an understanding of, and their relationships with, for example patients and regulatory
authorities.

Catalytic authenticity

Catalytic authenticity relates to how the study has served to participate in change, which can
mean both clarifying the focus as an issue, moving to eliminate or ameliorate the problem,
and/or sharpening values (Amin et al., 2020, p.9). Within our study we have aspired to establish
meaningful insights with pharmaceutical risk identification processes and therefore encourage
an improved understanding of risk identification within pharmaceutical projects. This may also
encourage practitioners to use our theoretical model when they structure the risk management
process within pharmaceutical projects.

65
Tactical authenticity

Tactical authenticity refers to if the participants of the study are able to “take the action(s) that
the inquiry implies or proposes.“ (Amin et al., 2020, p.9). We argue that this criterion is
fulfilled since our model gives our respondents and other stakeholders insights into how the
risk identification within pharmaceutical projects is conducted. This gives, particularly
participants, the opportunity to approach the process from our model’s framework.

66
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10. Appendices
Appendix 1. Keywords search results

Keyword Search result

Risk identification 5 330 000

Expert opinion risk identification 2 400 000

Pharmaceutical industry 3 210 000

Swedish pharmaceutical industry 115 000

Covid-19 effect on pharmaceutical industry 903 000

Covid-19 effect on Project management 2 220 000

Project management pharmaceutical 1 210 000

industry

Pharmaceutical industry risk 2 070 000

Pharmaceutical risk management 2 580 000

Risk identification project management 5 730 000

Unknown risks project management 1 070 000

Failed projects 2 180 000

Riskification 633

73
Appendix 2. Information form - English
Information form for participants

Risk identification within pharmaceutical projects

We are currently working on a degree project studying the risk identification process within
pharmaceutical projects in Sweden. You have been invited to take part in the project.

Before you decide whether to participate in our degree project, please take time to carefully
read through the following information about what it means to participate in this study.

What is the purpose of the study?

Our degree project is part of the Business Administration program at Umeå School of Business,
Economics and Statistics, Umeå University. Within the program we have explored project
management and therefore touched upon risk management. The purpose of this thesis is to
provide insights into the beginning stages of risk management for projects during Covid-19 in
Sweden, within the pharmaceutical industry, which is of crucial importance to our society. In
addition, we aim to elaborate how pharmaceutical companies have managed identifying risks
during the pandemic, where uncertainty is consistent. By exploring which strategies and
practices are successfully useful for pharmaceutical companies, we desire to bring value for
future research and practitioners when identifying risk and proceeding with projects.

Why have I been chosen?

We aim to interview people involved with (a) projects (b) within the pharmaceutical industry
(c) in Sweden.

Do I have to participate?
Your participation is voluntary based. Once you agree to participate, you will be given this
information sheet to keep and be asked to sign a consent form. Even though you decide to take
part, you can still decide to withdraw from the study at any time without an explanation if you
do not wish to explain.

If you wish to withdraw from the research after some data have been collected, you will be
asked if you are content for the data collected to be retained and included in the study. If you
prefer, the data collected can be destroyed and not included in the study. However, you cannot
withdraw the data from the study when the research has been completed and data analysis has
begun on May 1st, 2022.

If I take part in the research, what do I have to do?

If you decide to take part, we would like to conduct 1 to 2 interviews with you, ideally on
Zoom/Teams or via phone call. You will be asked a number of questions regarding (1) yourself
and your role within your organisation (2) your take on risk identification within projects (3)
your organisation's risk identification processes, before and during Covid-19.

We aim to ask open-ended questions and we can provide the questions in advance if you wish.
Each interview will last for around 45 minutes.

74
What will happen to the information I provide the researchers?
Personal details including your name and contacts will be kept confidential and not revealed to
third parties in compliance with academic research ethics and the rules and regulations of
processing personal data at Umeå University. More information can be found at:
[Link]

The consent forms we retrieve from the participants will be preserved in Umeå University
OneDrive with password protected. Personal information provided during the interviews such
as people’s names, places, name of the projects and occupation will be anonymized in the
interview transcripts. Specifically, we will assign pseudonyms to people’s names that you
mention in the interviews. The same pseudonyms strategy applies for places and businesses.
Occupation will be replaced by general terms such as Andrew’s job as a researcher became
‘job in education’. Researchers in our research project are the only ones who possess access to
the data. The data we collect from interviews i.e., audio files, transcripts and observation notes
will be encrypted and saved similar as the consent form, in a Umeå University OneDrive
account, protected by password. Researchers in our research program are the only ones who
have access to this data.

Quotes from the interview transcripts will be included in the thesis that we author. Your and
your organisation’s identities will remain anonymous in the interview quotes that will be used
in our papers.

Umeå University will be the organisation processing your personal information. In accordance
with the General Data Protection Regulation (GDPR) of the European Union, you have the
right to request information once a year, concerning what personal data Umeå University holds
on you. If the data that is collected about you is incorrect, you are entitled, as a data subject, to
correct it. Additionally, you are authorised to have personal data concerning you erased when
it is no longer needed for the purpose for which it was collected. However, the personal data
might not always be allowed to be erased due to other legislation that supersedes this rule.
Furthermore, you are entitled that the processing of personal data regarding you is limited to a
certain specific purpose only. You may complain about the processing of your personal data.
If there are no compelling reasons for the university to continue processing the personal data,
the university will stop processing.

If you have any request for your personal data, please contact Emma Nydén or Wilma Janzon
Hägglund. Our contacts are listed below.
You can also contact the Data Protection Officer at Umeå University, at pulo@[Link].
If you have any concerns about the university’s personal data rights practises you can lodge a
complaint to the supervisory authority, Datainspektionen. Information on how to proceed with
a complaint is available on their website, [Link]

What if something goes wrong?

Do not hesitate to contact us if you have any concerns or questions. Our contacts are provided
below.

How do I get access to the results of the study?

Please feel free to contact the responsible researchers if you have any questions regarding
publications or results of the study. If you wish to, we can provide the link or the finished copy
of our degree project to you when available.

75
What happens next?
If you agree to participate in this study, you will find a copy of the consent form below that
needs to be signed. You can keep this document and the consent form. We will keep another
copy of the consent form.

Thank you for your time!

For further information, please contact:

Wilma Janzon Hägglund
Researcher
Umeå School of Business, Economics and Statistics,
Umeå University
Email: Wilmajanzon@[Link]
Telephone: 072-726 64 44
Umeå universitet, 901 87 Umeå

Emma Nydén
Researcher
Umeå School of Business, Economics and Statistics,
Umeå University
Email: emma.nyden98@[Link]
Telephone: 070-955 93 48
Umeå universitet, 901 87 Umeå

Quang Evansluong
Supervisor
Umeå School of Business, Economics and Statistics,
Umeå University
Email: [Link]@[Link]
Telephone: 090-7867257
Samhällsvetarhuset, Biblioteksgränd 6, A36001
Umeå universitet, 901 87 Umeå

76
Appendix 3. Information form - Swedish
Informationsformulär för deltagare

Riskidentifiering inom farmaceutiska projekt

Vi arbetar just nu med ett examensarbete som studerar riskidentifieringsprocessen inom
läkemedelsprojekt i Sverige. Du har blivit inbjuden att delta i projektet.

Innan du bestämmer dig för om du vill delta i vårt examensarbete eller inte, ta dig tid att
noggrant läsa igenom följande information om vad det innebär att delta i denna studie.

Vad är syftet med studien?

Vårt examensarbete är en del av Civilekonomprogrammet på Handelshögskolan vid Umeå
universitet. Inom programmet har vi utforskat projektledning och därför berört riskhantering.
Syftet med detta examensarbete är att ge insikter i början av riskhantering för projekt i Sverige.
Dessutom strävar vi efter att utveckla hur läkemedelsföretag har lyckats identifiera risker under
pandemin, där osäkerheten är konsekvent. Genom att utforska vilka strategier och metoder som
framgångsrikt är användbara för läkemedelsföretag vill vi tillföra värde för framtida forskning
och praktiker när de identifierar risker och fortsätter med projekt.

Varför har jag blivit utvald?

Vi syftar till att intervjua personer involverade i (a) projekt (b) inom läkemedelsindustrin (c) i
Sverige.

Måste jag delta?

Ditt deltagande är frivilligt. När du samtycker till att delta kommer du att få detta
informationsblad att behålla och ombeds att underteckna ett samtyckesformulär. Även om du
bestämmer dig för att delta kan du när som helst välja att avbryta studien utan förklaring om
du inte vill förklara.

Om du vill dra dig ur forskningen efter att viss data har samlats in kommer du att tillfrågas om
du nöjer dig med att den insamlade informationen behålls och inkluderas i studien. Om du
föredrar det kan de insamlade uppgifterna förstöras och inte inkluderas i studien. Du kan dock
inte dra tillbaka data från studien när forskningen är klar och dataanalysen har påbörjats den 1
maj 2022.

Om jag deltar i forskningen, vad måste jag göra?

Om du bestämmer dig för att delta vill vi genomföra 1 till 2 intervjuer med dig, helst på
Zoom/Team eller via telefonsamtal. Du kommer att ställas ett antal frågor om (1) dig själv och
din roll inom din organisation (2) din inställning till riskidentifiering inom projekt (3) din
organisations riskidentifieringsprocesser, före och under Covid-19.

Vi strävar efter att ställa öppna frågor och vi kan tillhandahålla frågorna i förväg om du så
önskar. Varje intervju kommer att pågå i cirka 45 minuter.

77
Vad kommer att hända med informationen jag ger forskarna?
Personuppgifter inklusive ditt namn och dina kontakter kommer att hållas konfidentiella och
inte avslöjas för tredje part i enlighet med akademisk forskningsetik och reglerna för
behandling av personuppgifter vid Umeå universitet. Mer information finns på:
[Link]

De samtyckesformulär vi hämtar från deltagarna kommer att bevaras i Umeå universitet

OneDrive med lösenordsskydd. Personlig information som lämnas under intervjuerna såsom
personers namn, platser, namn på projekten och sysselsättning kommer att anonymiseras i
intervjuutskrifter. Specifikt kommer vi att tilldela pseudonymer till personers namn som nämns
i intervjuerna. Samma pseudonym strategi gäller för platser och företag. Yrke kommer att
ersättas av allmänna termer som att Andrews jobb som forskare blev "jobb inom utbildning".
Forskare i vårt forskningsprojekt är de enda som har tillgång till data. De data vi samlar in från
intervjuer, till exempel ljudfiler, utskrifter och observationsanteckningar, kommer att krypteras
och sparas på samma sätt som samtyckes formuläret, på ett OneDrive-konto vid Umeå
universitet, lösenordskyddat. Forskare i vårt forskningsprogram är de enda som har tillgång till
denna data.

Citat från intervjuutskrifterna kommer att ingå i den avhandling som vi skriver. Din och din
organisations identiteter kommer att förbli anonyma i de intervjucitat som kommer att
användas i våra arbeten.

Umeå universitet kommer att vara den organisation som behandlar dina personuppgifter. I
enlighet med Europeiska unionens allmänna dataskyddsförordning (GDPR) har du rätt att, en
gång per år, begära information om vilka personuppgifter Umeå universitet har om dig. Om
uppgifterna som samlas in om dig är felaktiga har du som registrerad rätt att korrigera dem.
Dessutom har du rätt att få personuppgifter om dig raderade när de inte längre behövs för det
ändamål för vilka de samlades in. Det kan dock hända att personuppgifterna inte alltid tillåts
raderas på grund av annan lagstiftning som ersätter denna regel. Vidare har du rätt att
behandlingen av personuppgifter om dig är begränsad till endast ett visst specifikt ändamål. Du
kan klaga på behandlingen av dina personuppgifter. Om det inte finns några vägande skäl för
universitetet att fortsätta behandlingen av personuppgifterna kommer universitetet att upphöra
behandlingen av dina personuppgifter.

Om du har någon begäran om dina personuppgifter, vänligen kontakta Emma Nydén eller
Wilma Janzon Hägglund. Våra kontaktuppgifter finns nedan.
Du kan också kontakta data skyddsombudet vid Umeå universitet, på pulo@[Link].
Om du har oro kring universitetets praxis för rätten om personlig information kan du lämna in
ett klagomål till tillsynsmyndigheten Datainspektionen. Information om hur du går till väga
med ett klagomål finns på deras hemsida, [Link]

Vad händer om något går fel?

Tveka inte att kontakta oss om du har några funderingar eller frågor. Våra kontaktuppgifter
finns nedan.

Hur får jag tillgång till resultaten av studien?

78
Kontakta gärna ansvariga forskare om du har frågor angående publikationer eller resultat av
studien. Om du vill kan vi tillhandahålla länken eller den färdiga kopian av vårt examensarbete
när det är tillgängligt.

Vad händer härnäst?

Om du samtycker till att delta i denna studie hittar du en kopia av samtyckesformuläret nedan
som måste undertecknas. Du kan behålla detta dokument och samtyckesformuläret. Vi kommer
att behålla ytterligare en kopia av samtyckesformuläret.

Tack för din tid!

För ytterligare information, vänligen kontakta:

Wilma Janzon Hägglund
Forskare
Handelshögskolan i Umeå
Umeå Universitet
Email: Wilmajanzon@[Link]
Telefon: 072-726 64 44
Umeå universitet, 901 87 Umeå

Emma Nydén
Forskare
Handelshögskolan i Umeå
Umeå Universitet
Email: emma.nyden98@[Link]
Telefon: 070-955 93 48
Umeå universitet, 901 87 Umeå

Quang Evansluong
Handledare
Handelshögskolan i Umeå
Umeå Universitet
Email: [Link]@[Link]
Telefon: 090-7867257
Samhällsvetarhuset, Biblioteksgränd 6, A36001
Umeå universitet, 901 87 Umeå

79
Appendix 4. Consent form - English
Consent form for participants

Risk identification within pharmaceutical projects

Please complete this form after you have been informed about the research project.

Name of the participant:

I hereby confirm that I am over 18 years old and…

I agree to take part in this research,

I have read and understood the study information form and been given the opportunity to ask
questions before agreeing to take part in the project,

I understand that I can withdraw from the study at any time without having to give an
explanation,

I understand that the interview will be audio-recorded and give permission for the researchers
to do so,

I give permission for direct quotes from the interview to be used for academic purposes under
the condition that I remain anonymous.

*By signing this consent form, you understand and agree to the terms stated above. *

Date:

Sign:

80
Appendix 5. Consent form - Swedish
Samtyckesformulär för deltagare

Risk identifiering inom farmaceutiska projekt

Fyll i detta formulär efter att du har blivit informerad om forskningsprojekt.

Namn på deltagaren:

Jag bekräftar härmed att jag är över 18 år och...

Jag går med på att delta i denna forskning,

Jag har läst och förstått information-formuläret och fått möjlighet att ställa frågor innan jag
tackar ja till att delta i projektet,

Jag förstår att jag kan dra mig ur studien när som helst utan att behöva ge en förklaring,

Jag förstår att intervjun kommer att spelas in på ljud och ger tillåtelse för forskarna att göra det,

Jag ger tillåtelse att direkta citat från intervjun används för akademiska syften under
förutsättning att jag förblir anonym.

*Genom att underteckna detta samtyckesformulär förstår och godkänner du villkoren som
anges ovan. *

Datum:

Signatur:

81
Appendix 6. Interview guide - English

Theme Questions Purpose Theory

Introduction ● Introduce ourselves and Prepare the (Saunders et al.,

the study. respondent for the 2019)
● Ask for permission to interview and inform
record them about their
● Review how their rights. Create a
information is handled. friendly atmosphere.
(GDPR + anonymous) Check that the
● Age, gender respondent meets the
requirements to
participate in the
study.

Background ● Can you tell us a little Get information about (Saunders et al.
about your role and the the person and the 2019)
company you work for? company as this is
● How long have you useful for
worked there? contextualising
● How long have you people's answers.
worked as a project
manager / within
projects?
● What is your education?
● What kind of
management training do
you have?
● What kind of projects do
you work on?
● How involved are you
usually in the risk
identification process?
● What does risk mean to
you as a project
manager? How would
you define it?

Pharmaceutical ● What would you say is Investigate how the (Brown & Grundy,
industry what characterises the pharmaceutical 2016)
pharmaceutical industry industry differs from
when compared to other other industries
industries?

Pharmaceutical ● What would you say is Get an insight into (Chauhan &
project management what sets projects in what characterises a Srivastava, 2014)
your industry apart from project in the
projects in other pharmaceutical
industries? industry
Are they more or less complex?)

82
During Covid-19 ● How has the pandemic Get an idea of what (Tirivangani et al.,
affected your job / role / the pandemic has 2021)
tasks? caused for change +
thoughts and feelings
about change

Classification of risks ● What would you say are Get to know how (Mohammad
the most common risks risks are seen and Sabbaghi &
in pharmaceutical grouped in projects + Allahyari, 2020;
projects? how the pandemic has George, 2020;
(How has this been affected by affected the approach Stulz, 2008).
the pandemic?)

● After you have identified

a risk, do you have any
procedure to ensure that
the risk is classified
correctly? And thus, end
up in the right area of
responsibility?
(Has this required new solutions
due to the pandemic?)

Risk identification ● Could you tell us a little Get an idea of how (Hoon Kwak and
about how you / your risk identification is Dixon, 2008)
company relate to risk carried out and how
identification? the pandemic has
● How do you identify affected the process
'common' risks?
● How would you say your
risk identification in
projects has been
affected by the
pandemic?
(Has it / has it been more difficult
or easier during the pandemic?)

Risk identification ● Are there any specific Understand which (Brown & Grundy,
techniques risk identification techniques are most 2016; Maytorena et
techniques that you used in practice and al., 2007; Charoo
usually use? If so, which why + the effect of & Ali, 2012)
ones, and why? the pandemic
(Have you had to use new
technologies due to the
pandemic?)

Experience ● What would you say are Create us a perception (Maytorena et al,.
the most important of how personality 2007; Hoon Kwak
characteristics when it versus education / and Dixon, 2008)
comes to identifying experience is
risks in the most prioritised and an idea
effective way? of how these factors
(Has this changed during the affect the result of
pandemic? risk identification

Contextualising ● How would you say that Examine geographical (Zahra, 2007;
(Sweden) regulatory laws and context and whether Picciotto, 2019;
regulations affect government and

83
 projects in the governing actors Baker and Welter,
pharmaceutical industry? influence projects and 2018)
(Has this changed during the attitudes to risk
pandemic? If so, how?)
● Do you have any
knowledge of whether
Sweden differs from
other countries when it
comes to regulatory laws
in the pharmaceutical
industry? If so, how do
they affect projects and
their propensity to take
risks?
(Have you noticed any difference
before / during the pandemic?)

Completion ● If you were to Give space for the (Saunders et al.

summarise what we respondent to 2019)
talked about in the highlight what it
interview, what would considers to be the
you say are the three most important thing
most important things to include +
when it comes to risk Give the respondent
identification? the chance to
● How would you sum up comment freely on
that the pandemic has the topic.
affected pharmaceutical
projects and their risk
identification?
● Do you have something
more you want to add
about the subject?

84
Appendix 7. Interview guide - Swedish

Tema Frågor Syfte Teori

Introduktion ● Presentera oss själva och Förbereda (Saunders et al.,

studien. respondenten för 2019)
● Fråga om tillåtelse att intervjun och
spela in informera om deras
● Gå igenom hur deras rättigheter. Skapa en
uppgifter hanteras. vänlig stämning.
(GDPR+anonymous) Kontrollera att
● Ålder, kön respondent uppfyller
kraven för att delta i
studien.

Bakgrund ● Kan du berätta lite om Få information om (Saunders et al.

din roll och företaget du personen och 2019)
jobbar för? företaget då detta är
● Hur länge har du jobbat användbart för att
där? kontextualisera
● Hur länge har du jobbat personers svar.
som projektledare/inom
projekt?
● Vad har du för
utbildning?
● Vad har du för
‘management training’?
● Vad för slags projekt
jobbar du inom?
● Hur involverad brukar
du vara i
riskidentifieringsprocess
en?
● Vad betyder risk för dig
som projektledare? Hur
skulle du definiera det?

Farmaceutiska ● Vad skulle du säga att Undersöka hur (Brown & Grundy,
industrin det är som kännetecknar läkemedelsindustrin 2016)
läkemedelsindustrin om urskiljer från andra
man jämför med andra industrier
industrier?

Farmaceutisk project ● Vad skulle du säga att Få en inblick i vad (Chauhan &
ledning det är som skiljer projekt som karaktäriserar ett Srivastava, 2014)
i din industri från projekt projekt inom
i andra industrier? läkemedelsindustrin
(Är de mer eller mindre
komplexa?)

Under Covid-19 ● Hur har pandemin Få en uppfattning till (Tirivangani et al.,

påverkat ditt jobb/din vad pandemin har 2021)
roll/dina arbetsuppgifter? orsakat för förändring
(kan du ge ett exempel? + tankar och känslor
kring förändring

85
Klassificering av ● Vad skulle du säga är de Få kännedom om hur (Mohammad
risker vanligaste riskerna i risker ses på och Sabbaghi &
pharmaceutiska projekt? grupperas i projekt + Allahyari, 2020;
(Hur har detta påverkats av hur pandemin har George, 2020;
pandemin, exempel) påverkat synsättet Stulz, 2008).

● Efter att ni har

identifierat en risk, har ni
något tillvägagångssätt
för att säkerhetsställa att
risken klassificeras rätt?
(exempel) Och därmed
hamnar inom rätt
ansvarsområde?
(Har detta krävt nya lösningar pga
pandemin?)

Risk identifiering ● Skulle du kunna berätta Få en uppfattning om (Hoon Kwak and

lite om hur du/ditt hur riskidentifiering Dixon, 2008)
företag förhåller er till genomförs och hur
riskidentifiering? pandemin har
● Hur gör ni när ni ska påverkat processen
identifiera ‘vanliga’
risker?
● Hur skulle du säga att
eran riskidentifiering
inom projekt har
påverkats av pandemin?
(Är det/har det varit svårare eller
lättare under pandemin?)

Risk identifierings ● Finns det någon/några Förstå vilka tekniker (Brown & Grundy,
tekniker specifika tekniker för som är mest använda i 2016; Maytorena et
riskidentifiering som praktiken och varför al., 2007; Charoo
du/ni brukar använda er + pandemins effekt & Ali, 2012)
av? Isåfall, vilka, och
varför?
(Har ni varit tvungna att använda
nya tekniker pga pandemin?)

Erfarenhet ● Vad skulle du säga är de Skapa oss en (Maytorena et al,.

viktigaste egenskaperna perception om hur 2007; Hoon Kwak
när det kommer till att personlighet kontra and Dixon, 2008)
identifiera risker på mest utbildning/erfarenhet
effektiva sätt? prioriteras samt en
(Har detta förändrats under uppfattning om hur
pandemin?) dessa faktorer
påverkar resultatet av
riskidentifiering

Kontextualisering ● Hur skulle du säga att Undersöka (Zahra, 2007;

(Sverige) regulatoriska lagar och geografiskt Picciotto, 2019;
regler påverkar projekt i sammanhang och ifall Baker and Welter,
läkemedelsindustrin? regering och styrande 2018)

86
 (Har detta förändrats under aktörer påverkar
pandemin? Om ja, Hur?) projekt och attityden
● Har du någon vetskap till risk
om Sverige urskiljer sig
från andra länder när det
gäller regulatoriska lagar
inom
läkemedelsindustrin?
Isåfall, hur påverkar dem
projekt och
benägenheten till risk?
(Har du märkt någon skillnad på
innan/under pandemin?)

Avslutning ● Om du ska sammanfatta Ge utrymme till att (Saunders et al.

det vi har pratat om i låta respondenten 2019)
intervjun, vad skulle du lyfta fram vad den
säga är det tre viktigaste anse är det viktigaste
sakerna när det kommer att ta med +
till riskidentifiering? Ge respondenten
● Hur skulle du chansen att
sammanfatta att kommentera fritt
pandemin har påverkat kring ämnet.
pharmaceutiska projekt
och deras
riskidentifiering?
● Har du något mer du
önskar tillägga om
ämnet?

87
Business Administration SE-901 87 Umeå [Link]

88