Medical Director/ Senior Patient Safety Physician

About the Company

Responsibilities

• ● 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, characterise, 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 minimisation 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 labelling 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

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
• ● 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 post-marketing activities
• ● Strong communication and influencing skills, with the ability to work effectively across cross-functional and cross-cultural teams
• ● Ability to balance scientific rigor with business priorities while maintaining a clear focus on patient safety
• ● Fluency in written and spoken English
• ● It would be valuable if you also have:
• ● An MSc, PhD , or other advanced scientific qualification
• ● Ability to interpret and apply epidemiological data
• ● Additional training in Pharmaceutical Medicine or a related discipline
• ● Why 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.