Director, Principal Patient Safety Scientist

Do you have deep expertise in healthcare safety and pharmacovigilance, with experience leading safety strategy across complex development programmes?We are now recruiting for a Director, Principal Patient Safety Scientist to join our team in Gothenburg. This is a strategic role for an experienced safety scientist who will provide expertise across multiple products, or a single highly complex product, at different stages of development. Working closely with the Global Safety Programme Lead (GSPL) and other PV Scientists, you will lead safety strategy for key documents, regulatory deliverables, and risk management activities, while also contributing to cross-functional initiatives and the continued evolution of patient safety practices across <AstraZeneca.At> AstraZeneca, we are dedicated to meeting the unmet needs of patients worldwide by discovering, developing, and delivering innovative medicines and healthcare solutions. Within Global Patient Safety, we provide expert safety leadership across the product lifecycle, shaping proactive safety strategies, delivering high-quality regulatory submissions, and driving robust risk management to support patients, healthcare professionals, and regulators <worldwide.In> this role, you willLead proactive pharmacovigilance and risk management strategy for complex or multiple products across development, shaping the safety components of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in close partnership with the GSPL and cross-functional colleagues.Serve as a subject matter expert within the therapeutic area and across multiple products, providing strategic guidance on safety issues and regulatory requirements. You will act as Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products and lead presentations on significant safety topics to the Safety Information Review Committee (SIRC).Drive safety strategy for key regulatory deliverables, including PBRERs, PSURs, and DSURs, ensuring high-quality outcomes delivered in line with agreed timelines and <processes.Support> major regulatory submissions for new products, formulations, and indications, including NDA/BLA and MAA submissions, working closely with the GSPL and other functional experts.The role includes contributing patient safety expertise to third-party contracts and agreements, taking accountability for resolving complex safety issues, and helping build cross-functional alignment. You may also contribute to due diligence activities, lead or support process improvement initiatives, and provide training and mentorship to new GSPL and PV Scientists.Essential requirementsDegree in life sciences, pharmacy, or nursing, together with significant experience in Patient Safety and/or clinical drug developmentFluency in written and spoken EnglishAdvanced knowledge of pharmacovigilance regulationsStrong experience leading safety strategy across complex products or development programmesAbility to work effectively across global, cross-functional teamsStrategic approach, sound scientific judgement, and strong problem-solving skillsAbility to influence, mentor, and build alignment across teamsDesirable requirementsMD, MSc, or PhD in a relevant scientific disciplineAdvanced understanding of epidemiologyExperience contributing to due diligence activitiesExperience leading cross-functional process improvement initiativesExperience interacting with health authorities and regulators, including supporting regulatory discussions and responsesExperience mentoring or developing other safety professionalsWhat we’re looking forTo be successful in this role, we see that you bring scientific credibility, critical thinking, and the confidence to lead through complexity. You combine sound scientific judgement with strong problem-solving skills and can work effectively across global, cross-functional <teams.You> anticipate future needs, identify opportunities, and develop effective solutions to complex safety challenges. You are collaborative and decisive, with the ability to influence others, build alignment across teams, and deliver high-quality outcomes across multiple products or programmes. You are also committed to developing people and strengthening organisational capability through mentoring, leadership, and knowledge-sharing.Why AstraZeneca?At AstraZeneca, we’re dedicated to being a Great Place to Work, where you can push the boundaries of science and make a meaningful impact for patients, society, and the future of medicine. Our inclusive culture champions diversity, collaboration, and continuous learning, supporting our people to grow and develop throughout their careers.When we bring together different perspectives and expertise, we unlock bold thinking with the power to deliver life-changing medicines. In-person working gives us the platform we need to connect, collaborate at pace, and challenge perceptions. That’s why we work, on average, a minimum of four days per week from the office, while balancing this with individual flexibility.What’s next?Ready to take the next step? We’d love to hear from you! Please submit your CV and cover letter, no later than 23rd of <August.To> help us review your application smoothly, please combine your CV and cover letter into one document before <uploading.Date> Posted06-aug.-2026Closing Date23-aug.-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.