Senior Safety Epidemiology Lead — Real-World Evidence

AstraZeneca; Luton; Hybrid; GBP 150,000 - 190,000; Full time

Benefits offered by this job

Flexible benefits fund

Holiday purchase

Pension contributions

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Job summary

AstraZeneca in Luton seeks an Associate Director, Safety Epidemiology to lead PASS and related real-world evidence studies, coordinating across Global Patient Safety and cross-functional partners. You will shape epidemiology strategies for regulatory submissions and risk management plans, while mentoring CROs and external partners.

You will apply advanced epidemiology methods to diverse data sources and champion rigorous safety evidence to support regulatory decisions and lifecycle management.

Qualifications

• Ph.D. or MD/PharmD with MSc/MPH and health-care experience.
• Experience in pharmacoepidemiology and pharmacovigilance study design and execution.
• Pass/Post-authorisation safety studies experience a plus.
• Regulatory and safety reporting knowledge for global authorities.

Responsibilities

• Lead end-to-end PASS, PMCs/PMRs and other pharmacovigilance studies.
• Provide epidemiology strategy to regulatory deliverables including RMPs.
• Collaborate with Global Patient Safety, Regulatory Affairs, Biostatistics and CROs.
• Ensure data quality, causal inference and transparent reporting.

Skills

Pharmacoepidemiology

Regulatory science

Epidemiology

RWE methods

Education

Ph.D. in pharmacoepid epidemiology

MD/PharmD with MSc/MPH

Tools

EHR/claims data analysis

Job description

AstraZeneca in Luton seeks an Associate Director, Safety Epidemiology to lead PASS and related real-world evidence studies, coordinating across Global Patient Safety and cross-functional partners. You will shape epidemiology strategies for regulatory submissions and risk management plans, while mentoring CROs and external partners.

You will apply advanced epidemiology methods to diverse data sources and champion rigorous safety evidence to support regulatory decisions and lifecycle management.