Medical Director/ Senior Patient Safety Physician

Drive patient safety at the forefront of global drug development!At AstraZeneca, we’re dedicated to being a Great Place to Work. Here, you’re empowered to push the boundaries of science, unleash your entrepreneurial spirit, and make a meaningful difference to medicine, patients, and society. We foster an inclusive culture built on diversity, collaboration, and a commitment to lifelong learning, growth, and development.Join AstraZeneca in Gothenburg, Sweden as a Medical Director / Senior Patient Safety Physician and play a pivotal role in shaping the safety strategy behind innovative medicines that can transform patients’ lives.This is a high-impact leadership role for an experienced physician with deep expertise in drug development, pharmacovigilance, and benefit-risk evaluation. You will lead the clinical safety strategy for assigned AstraZeneca drug projects and products across all stages of development and, where relevant, in the post-marketing setting.What’s in it for you?You’ll work with key internal and external stakeholders, provide scientific leadership, and influence safety strategies that matter to patients around the world. The role offers broad exposure across Research & Development, with insight into how strategic direction is shaped within the clinical organisation and how critical decisions are made throughout the drug development lifecycle.Working closely with cross-functional teams in Clinical Development, you will bring complex issues into clinical context and support informed, science-based decisions. It is also an excellent opportunity to continue growing your expertise in drug development, science, and leadership within a global, innovation-driven environment.What you’ll doYou will lead the clinical safety strategy for assigned products and programs, representing both the patient and Health Authority perspective. You will provide senior medical expertise on the safety profile of products and disease areas, ensuring robust and proactive safety assessment throughout development and post-marketing.Your responsibilities will include:Leading clinical safety strategy and governance for assigned projects and products, including implementation and communication at project team and governance levelDriving safety assessment, evaluation, and risk management for AstraZeneca products or product groups in clinical development and/or the post-marketing settingReviewing adverse events and broader safety information to help predict, characterise, and manage the safety profile of compounds and marketed productsIdentifying updates to reference safety information and driving proactive risk management initiatives in line with global regulatory requirementsDefining identified and potential risks, proposing mitigation and minimisation measures, and contributing to safety go/no-go criteria, submission strategies, and benefit-risk assessmentsProviding medical input into core safety documents, including PBRERs, PSURs, PADERs, DSURs, renewal documentation, and other regulatory safety reportsEnsuring consistent safety messaging across regulatory documents and contributing to responses to regulatory authority questions and labelling updatesContributing to signal detection, signal evaluation, and surveillance activities, including medical review of individual safety cases where appropriateProviding medical input into Development Core Safety Information (DCSI) and other product safety documentationLeading patient safety contributions to global regulatory submissions, including NDA, BLA, and MAA submissions for new products, formulations, or indicationsSupporting clinical development planning through strategic safety input into project-specific safety requirements, investigator brochures, protocols, informed consent documents, final study reports, and data monitoring committee materials as appropriateCollaborating with experts across AstraZeneca, including colleagues in Patient Safety, Clinical Development, Regulatory Affairs, pre-clinical safety, safety science, and safety informaticsContributing to urgent safety issue management, governance discussions, inspection and audit readiness, process improvement initiatives, and mentoring junior colleagues where relevantEssential requirementsMedical degree such as MD or MBBSAt least 2 years of post-registration clinical experienceAt least 5 years of experience in Drug Development and/or Patient Safety, with the majority ideally gained in industry Patient SafetyStrong understanding of the pharmaceutical/biopharmaceutical industry, particularly clinical research and global regulatory requirementsExperience in expedited and periodic safety reporting, signal detection, safety evaluation, and risk managementStrong clinical credibility and scientific judgement, with the ability to interpret complex safety data and apply benefit-risk thinkingAbility to translate safety insights into clear, practical actions across development and post-marketing activitiesStrong communication and influencing skills, with the ability to work effectively across cross-functional and cross-cultural teamsAbility to balance scientific rigor with business priorities while maintaining a clear focus on patient safetyFluency in written and spoken EnglishDesirable requirementsIt would be valuable if you also have:An MSc, PhD, or other advanced scientific qualificationExperience across multiple therapeutic areas or functionsExperience supervising, mentoring, or developing colleagues in Patient SafetyAbility to interpret and apply epidemiological dataAdditional training in Pharmaceutical Medicine or a related disciplineWhy AstraZeneca?Our purpose is ambitious, and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with urgency. We are ambitious, take informed risks, and learn from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first.If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do, we’d love to hear from you.Join us and be part of an outstanding place to work — an environment that energizes and empowers each of us to achieve our personal and organizational goals.What’s next?Ready to take the next step? Please submit your CV and cover letter no later than 31st of <August.To> help us review your application smoothly, please combine your CV and cover letter into one document before <uploading.Date> Posted13-aug.-2026Closing Date31-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.