Pharmaceutical Project Risk Identification : A Qualitative Study of Swedish Companies' Pharmaceutical Project Risk Identification Process

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.