Associate Director, Safety Epidemiology – Global Patient Safety

Location:

Luton, UK

AstraZeneca’s Safety Epidemiology team leads the strategy, design, execution, and delivery of post‑authorisation safety studies (PASS) across a broad portfolio of marketed and pipeline medicines. We are also responsible and accountable for generating epidemiological insights to investigate safety signals that helps to inform regulatory decision‑making, benefit–risk assessment, and risk management for AstraZeneca products across multiple therapy areas.

The Associate Director, Safety Epidemiology is a senior scientific role responsible for the end‑to‑end delivery of complex post‑authorisation safety studies using real‑world data. The candidate will collaborate across Global Patient Safety, Regulatory Affairs, Biostatistics, Clinical, and external partners to produce high‑quality, decision‑ready evidence. The role also provides epidemiology strategy and input to key regulatory deliverables, including Risk Management Plans, safety signal evaluations, and diversity plans, to help ensure our medicines are safe and effective for all patients.

• Lead study strategy and delivery:
  Direct the design, protocol development, analysis plan, execution, interpretation, and reporting of PASS, PMCs/PMRs, and other pharmacovigilance studies using EHR/claims and other real‑world data sources.
• Advance regulatory science:
  Develop, rationalise, and defend epidemiological approaches with health authorities (e.g., FDA, EMA) and ensure regulatory commitments are met with rigor and on time.
• Characterise benefit–risk:
  Generate and synthesise epidemiological evidence to inform safety profiles, support signal assessments, and supply qualitative and quantitative benefit–risk evaluations.
• Enable evidence diversity:
  Lead epidemiology strategies for FDA clinical trial diversity plans and conduct diversity focused real‑world evidence analyses across race/ethnicity, age, and gender.
• Coordinate external collaborations:
  Select, lead, and mentor CROs and academic partners to ensure methodological quality, visibility, and reproducibility.
• Conduct literature syntheses:
  Plan and complete targeted and systematic literature reviews on safety topics and provide critical appraisal with clear recommendations.
• Influence cross-functional strategy:
  Provide authoritative epidemiology input to Global Patient Safety and therapy area teams to inform development and lifecycle decisions.
• Uphold methods and standards:
  Champion best practices in pharmacoepidemiology, data quality, causal inference, confounding control, and transparent reporting.

• Patient impact:
  Evidence produced directly supports regulatory actions and risk minimisation measures that protect patient safety globally.
• Scale and scope:
  Contributions span nearly 100 products across multiple therapy areas, addressing complex and novel safety questions.
• Methodological leadership:
  Application of advanced methods to complex real‑world data to elevate how RWE informs pharmacovigilance and regulation.
• Stakeholder influence:
  Regular engagement with senior leaders and regulators; findings inform decisions of strategic importance.

• Scientific leadership:
  Build visibility as a subject matter expert in pharmacoepidemiology and RWE for safety.
• Portfolio breadth:
  Work across diverse therapy areas and data environments (EHR, claims, registries, primary data collection).
• Mentorship and collaboration:
  Guide external partners and provide input to internal capability building; opportunities to mentor junior scientists.
• External engagement:
  Publish and present methods and findings; leading to standards for PASS/RWE…