Director, Global Safety Lead

About the role

Servier, a Boston‑based biopharmaceutical company, is seeking a Director, Global Safety Lead to join its Global Safety organization. The role will partner with safety leads in Boston and Suresnes to oversee safety and risk management for both development and marketed compounds, ensuring compliance with internal procedures and regulatory requirements.

Key responsibilities

• Lead signal detection activities, including planning, data retrieval, analysis, and authoring sections of Safety Evaluation Reports (SER) or Development Safety Evaluation Reports (DSER).
• Generate and coordinate aggregated safety reports such as PBRER, PSUR, PADER, DSUR, INDAR, and six‑monthly line‑listings for both development and marketed products.
• Coordinate risk evaluation and mitigation activities, authoring components of Development Risk Management Plans (DRMP), RMPs, and REMS.
• Prepare and review safety sections of clinical documents (protocols, ICFs, CSR) and validate CRF AE/SAE pages.
• Conduct periodic quality checks of vendor‑generated ICSR databases and document Analysis of Similar Events (AOSE).
• Support regulatory filings (NDA, sNDA, MAA) and respond to Health Authority queries.
• Represent the Medical Safety Division on project and study teams and act as Global Safety representative during audits and inspections.

Required profile

• Medical Doctor (MD) or PharmD with a minimum of 10 years of drug safety experience.
• Extensive knowledge of pharmacovigilance, risk management, and applicable safety regulations.
• Proven ability to produce aggregate safety reports and conduct signal detection across early‑stage to post‑approval settings.
• Experience working in a fast‑paced, global, cross‑functional environment.

Required skills

• Microsoft Excel
• Microsoft Word
• Microsoft PowerPoint

What we offer

• Salary range $248,000 – $299,000 with short‑term and long‑term incentive programs.
• Comprehensive benefits including medical, dental, vision, unlimited sick/flex time, 401(k), life and disability insurance, and recognition programs.
• Hybrid work model (2‑3 days onsite in Boston) with occasional travel to France headquarters.