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The Medical Director, Patient Safety Physician is: Responsible for the Clinical Safety strategy for assigned AstraZeneca-MedImmune drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level. Responsible for the continued safety assessment, evaluation and risk management of AZ products or product groups in various stages of clinical development and/or the post‑marketing setting. Responsible for continuous efficient evaluation of adverse event and all other safety information in order to predict and manage the safety profile senza compounds in clinical development and marketed products through identifying the need for update to reference safety information and drive proactive implementation of risk management initiatives in accordance with global regulatory requirements. Provides consistent communication of safety topics across all regulatory safety documents, eg Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs) and Development Safety Update Reports (DSURs), for assigned product(s)/program(s). Proactively evaluates the clinical implications of safety data from pre‑clinical studies, clinical studies, literature and other information sources in order to predict / establish the safety profile of compounds in clinical development, including employing expert groups and methodologies such as Safety Knowledge Groups (SKG’s), Safety Science, Informatics expertise, modeling and simulation to manage the risk to patients. Pre‑clinical safety, Safety Knowledge Groups, Safety Informatics Scientists and Safety Science), as well as colleagues from all three Science Units as leader/member of a Safety Management Team)/ MedImmune Safety Review Team or as a member of other cross‑functional project teams, thereby promoting high quality evaluation of safety data. Safety Governance and Risk Management activities Working with the Safety Team, be responsible for the Clinical Safety strategy for assigned AstraZeneca‑MedImmune drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level. safety go‑no go criteria for the clinical programme; safety submission strategies; response to regulatory safety queries and definition of the risk component of the benefit/risk assessment. Reviews and endorses the core Patient Risk Management Plan (PRMP)/Core Patient Risk Log. Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation biades in the core PRMP(phi), MedImmune dRMP, CPRL and globally reviewed LRMPs. Represents PS on cross‑functional Clinical Teams and/or Project Teams for developmental and/or marketed products. Provides medical input to ensure that risk‑minimisation strategies are implemented appropriately in relevant documents such as product reference safety information rotor. Provides strategic clinical safety input into Clinical Development planning activities in accordance with PS Operating Model and Science Unit Service Level agreements. Provides strategic and medical input to project specific safety requirements (PSSR). Reviews and provides technical input and approval for investigator brochures, protocols, informed consents, final study reports and external data monitoring committees as appropriate. Provides input on cross‑functional ad‑hoc teams set up to address urgent and important safety issues. May present safety information at clinical investigator and commercial meetings. Facilitates establishment of a Safety Management Team/MedImmune Safety Review Team as necessary. Provides medical input into Identification and utilisation of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals. Collaborates with external provider representatives in routine signal management activities. Discusses the results of data evaluation with the Surveillance Team and/or appropriate key stakeholders, eg Patient Safety VP TA, QPPV/Deputy QPPV. Provides medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data. Provides strategic input into responses to regulatory requests for local label deviations from the company core safety documentation. In consultation with the PS scientist/year Clinical representatives, prepares the Developmental Core Safety Information (DCSI) for assigned development products. Provides the patient safety contribution to global regulatory submissions (NDA, BLA, MAA etc) for new products, formulations or indications. Contributes to and/or reviews the PS component of Safety Agreements Participates in AZ internal meetings with project focus. May provide support to AZ Legal for product liability litigation, as appropriate. Raises concerns/issues to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated. May mentor and train junior members of the team in signal evaluation methodology, risk management and preparation of safety reports and other documents. Collaborates effectively in cross‑functional and cross‑cultural project teams and environments, and work with external providers. At least 2 years of Drug Development/Patient Safety experience (the majority of which should be in industry in Patient Safety) with clear evidence of delivery NB: It is not mandatory to meet the minimum requirements for length of experience or to have completed the UK Higher Medical Training in Pharmaceutical Medicine; these details are intended to be indicative of the level of knowledge, expertise and recognition required of an individual in this job/office. Physicians will generally be expected to have completed Higher Medical Training in Pharmaceutical Medicine MSc/PhD in scientific discipline Experience of supervising Patient Safety colleagues A demonstrated ability to understand epidemiological data Date Posted: 12-Jan-2026 Closing Date: 20-Feb-2026 AstraZeneca embraces diversity-step and equality of opportunity. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
