Posted 5 days ago

Director, Principal Patient Safety Scientist

SE10 AstraZeneca AB Company Sweden, Sweden - Gothenburg
Onsite Full Time

Job description

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 23rd of August. To help us review your application smoothly, please combine your CV and cover letter into one document before uploading. Date Posted 06-aug.-2026 Closing Date 23-aug.-2026 Our 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.