Medical Director, Senior Patient Safety Physician

Job Title

Medical Director, Senior Patient Safety Physician

3 days onsite in Luton, UK

• Develop and implement the Clinical Safety strategy for assigned drug projects and products throughout all stages of development and when on the market.
• Communicate the strategy at the project team and governance level, and oversee continued safety assessment, evaluation, and risk management of AZ products or product groups.
• Manage the continuous efficient evaluation of adverse event and all other safety information.
• Provide consistent communication of safety topics across all regulatory safety documents, including PBRERs, PADERs, DSURs and others for assigned products/programs.
• Proactively evaluate clinical implications of safety data from pre‑clinical studies, clinical studies, and literature to predict and establish the safety profile of compounds in clinical development.
• Employ expert groups and methodologies such as Safety Knowledge Groups (SKGs), Safety Science, Informatics expertise, modelling and simulation to manage patient risk.
• Participate in all safety surveillance activities, including medical review of individual safety cases, signal detection, evaluation and SERM activities for all products in area of responsibility.
• Review periodic reports (PBRERs, PSURs, DSURs) and renewal documentation submitted to regulatory agencies, and contribute to global regulatory submissions (NDA, BLA, MAA) for new products, formulations or indications.

• Medical degree (MD, MBBS, etc.).
• At least 2 years of clinical experience post‑registration.
• High level of medical competence, able to balance with industry standards to achieve business goals.
• Minimum 4 years of Drug Development/Patient Safety experience, the majority in industry, with clear evidence of delivery.
• Detailed knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements (BLA, NDA, MAA) and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management.

• MSc or PhD in a scientific field.
• Ability to work across therapeutic areas and functions.
• Experience leading and inspiring Patient Safety colleagues.
• Demonstrated ability to understand epidemiological data.

• Competitive salary and remuneration package.
• Flexible employee benefits fund, including holiday purchase and flexible time off.
• Pension contributions.
• Share Save Plans.
• Performance recognition scheme.

Our mission is to build an inclusive and equitable environment. We welcome and consider applications from all qualified candidates, regardless of characteristics, and offer reasonable adjustments to help all candidates perform at their best.