Patient Safety Epidemiology Associate Director

General Summary

The Patient Safety Epidemiology Associate Director leads safety and regulatory epidemiology activities for Vertex products across multiple therapeutic areas and throughout all phases of lifecycle. This includes execution of post-marketing regulatory study research strategies, leading epidemiologic feasibility assessments, development of epidemiologic study designs, overseeing study implementation, interpreting findings, and communicating to internal and external audiences.

• Contribute to safety risk management, signal detection, benefit/risk assessments, and post-marketing regulatory research strategies.
• Research disease areas and events of interest; evaluate data sources and collection approaches; apply subject matter expertise to design observational studies; develop epidemiology sections for regulatory documents; implement post-marketing regulatory research strategy.
• Communicate safety and regulatory epidemiologic strategy to product teams.
• Lead all stages of regulatory post-marketing studies: feasibility, design/protocol development, execution, and dissemination to internal/external stakeholders.
• Support publications strategy (conference abstracts, presentations, peer-reviewed manuscripts).
• Lead epidemiology sections for Risk Management Plans (EU RMP, REMS) and other regulatory filings (NDA, PSUR).
• Conduct systematic and targeted epidemiologic literature reviews.
• Support signal detection analyses (e.g., FAERS, Vigibase, Sentinel).
• Lead study execution teams; participate in strategic meetings; collaborate cross-functionally.
• May supervise interns and/or contractors.

• Pharmacoepidemiologic methods and pharmacovigilance regulations; strong study design methodology.
• Strong knowledge of pharmacovigilance guidelines and regulations.
• Excellent verbal/written communication; independent decision-making; project management; collaboration in a matrix environment.

• PhD in epidemiology required.
• Typically 5 years’ experience in pharmaceutical/biotechnology industry, CRO, or academic setting (or equivalent).