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Director, Principal Patient Safety Scientist

AstraZeneca AB

Location
Mölndal, SE
Workplace
On-site
Job type
Full-time
Posted
Today
Source
Arbetsförmedlingen
Apply on company site
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 will · Lead 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 requirements · Degree in life sciences, pharmacy, or nursing, together with significant experience in Patient Safety and/or clinical drug development · Fluency in written and spoken English · Advanced knowledge of pharmacovigilance regulations · Strong experience leading safety strategy across complex products or development programmes · Ability to work effectively across global, cross-functional teams · Strategic approach, sound scientific judgement, and strong problem-solving skills · Ability to influence, mentor, and build alignment across teams Desirable requirements · MD, MSc, or PhD in a relevant scientific discipline · Advanced understanding of epidemiology · Experience contributing to due diligence activities · Experience leading cross-functional process improvement initiatives · Experience interacting with health authorities and regulators, including supporting regulatory discussions and responses · Experience mentoring or developing other safety professionals What we’re looking for To 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 2ndNovember.

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