Director Safety Epidemiology

The Senior Director develops and leads global pharmacovigilance epidemiology strategy and deliverables in partnership with Patient Safety and Regulatory leaders, providing scientific guidance as needed. The role also coordinates with local markets on mandated PARCS that require local real-world evidence. Working across Global Patient Safety, Regulatory, Global and Local Medical, and R&D, the Senior Director shapes strategic epidemiology and pharmacovigilance study plans and ensures that studies are designed and delivered in accordance with regulatory requirements and anticipated requests from the EMA, FDA and other health authorities.

• Deliver high-quality, scientifically robust evidence on time and within budget.
• Ensure projects are appropriately resourced.
• Develop and execute the Safety Epidemiology strategy in collaboration with senior leaders across Global Patient Safety, Medical Affairs and Clinical. Use AI to scale evidence generation and analytical workflows, expand internal capacity, and reduce costs.
• Recruit and assign epidemiologists with the appropriate skills to deliver Safety Epidemiology activities against quality, timeline, budget and performance targets.
• Partner with cross-functional teams to determine project resource needs.
• Develop and maintain the Safety Epidemiology capability strategy, proactively addressing skills gaps through training, capability-building and partnerships.
• Partner with Capacity Management to forecast resources accurately and develop flexible staffing solutions that support project delivery, employee development and succession planning.
• Motivate and develop team members, providing guidance on relevant Individual Development Plans.
• Ensure compliance with applicable policies and SOPs.
• Provide technical and strategic direction through coaching and leadership review of key deliverables, including MARC materials.
• Help drive the strategic vision and development of a world‑class safety epidemiology and real‑world evidence capability.
• Establish and manage master service agreements with external providers as required.
• Strengthen AstraZeneca's reputation and expertise in epidemiology policy, planning and evidence generation through participation in relevant external forums and professional groups.

Provide line management for Safety Epidemiology team members, including:

• Promote effective communication within and across departments.
• Recruit, retain and develop staff through targeted capability-building and career opportunities.
• Manage performance, complete assessments and make reward recommendations for direct reports.
• Implement and administer organisational policies.
• Maintain an environment that attracts, develops and retains highly qualified employees.
• Ensure direct reports adhere to SHE standards and maintain an appropriate work‑life balance.
• Maintain effective succession plans.

The Senior Director will lead a team of 10‑20 epidemiologists and oversee contracted resources as needed.

• Ph.D. in epidemiology and experience in the health care environment. Alternatively, an MSc or MPH with substantial experience in the health care environment or equivalent.
• Proven leadership experience in Safety Epidemiology, Pharmacoepidemiology or Real‑World Evidence within the pharmaceutical or healthcare sector.
• Extensive experience working with primary and secondary data, both US and global.
• Significant relevant hands on experience in the pharmaceutical/biotechnology industry
• Experience managing external partnerships and service providers, including master service agreements.
• Line management experience
• Experience of regulatory interactions
• Experience managing external partnerships and service providers, including master service agreements.
• Experience leading post‑authorization safety studies or…