Medical Director​/ Senior Patient Safety Physician

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 organization 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 do

You 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 level
• Driving safety assessment, evaluation, and risk management for AstraZeneca products or product groups in clinical development and/or the post-marketing setting
• Reviewing adverse events and broader safety information to help predict, characterize, and manage the safety profile of compounds and marketed products
• Identifying updates to reference safety information and driving proactive risk management initiatives in line with global regulatory requirements
• Defining identified and potential risks, proposing mitigation and minimization measures, and contributing to safety go/no-go criteria, submission strategies, and benefit-risk assessments
• Providing medical input into core safety documents, including PBRERs, PSURs, PADERs, DSURs, renewal documentation, and other regulatory safety reports
• Ensuring consistent safety messaging across regulatory documents and contributing to responses to regulatory authority questions and labeling updates
• Contributing to signal detection, signal evaluation, and surveillance activities, including medical review of individual safety cases where appropriate
• Providing medical input into Development Core Safety Information (DCSI) and other product safety documentation
• Leading patient safety contributions to global regulatory submissions, including NDA, BLA, and MAA submissions for new products, formulations, or indications
• Supporting 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 appropriate
• Collaborating with experts across AstraZeneca, including colleagues in Patient Safety, Clinical Development, Regulatory Affairs, pre-clinical safety, safety science, and safety informatics
• Contributing to urgent safety issue management, governance discussions, inspection and audit readiness, process improvement initiatives, and mentoring junior colleagues where relevant

Essential requirements

• Medical degree such as MD or MBBS
• At least 2 years of post-registration clinical experience
• At least 5 years of experience in Drug Development and/or Patient Safety, with the majority ideally gained in industry Patient Safety
• Strong understanding of the pharmaceutical/biopharmaceutical industry, particularly clinical research and global regulatory requirements
• Experience in expedited and periodic safety reporting, signal detection, safety evaluation, and risk management
• Strong clinical credibility and scientific judgement, with the ability to interpret complex safety data and apply benefit-risk thinking
• Ability to translate safety insights into clear, practical actions across development and…