Director, Global Safety & Risk Lead

Servier Pharmaceuticals; Boston (MA); Hybrid; USD 248,000 - 299,000; Full time

Job summary

Servier is seeking a Director, Global Safety Lead to lead safety and risk management for development and marketed compounds. The role collaborates with Boston and Suresnes teams in a global safety organization.

The candidate will oversee medical review, signal detection, safety reporting, and regulatory interactions while guiding safety strategy and compliance across phases and markets. Hybrid Boston-based role with occasional travel.

Qualifications

• MD/PharmD with at least 10 years in drug safety pre- and post-approval settings.
• Experience producing aggregate safety reports and signaling activities.
• Knowledge of safety regulations and clinical trials.

Responsibilities

• Lead signal detection activities for development and marketed compounds.
• Generate and coordinate aggregated safety reports (PBRER, PSUR, PADER, DSUR, etc.).
• Lead risk evaluation and mitigation activities for development and marketed compounds.
• Prepare and review safety sections of documents and validate CRF AE/SAE pages.
• Conduct safety reviews and quality checks of vendor databased IC.
• Support regulatory filings and Health Authority interactions.
• Represent Medical Safety in project teams and study teams.
• Maintain and update safety sections of CCDS/CCSI/RSI/IB or local PI.
• Develop SOPs and document templates related to safety activities.

Skills

Pharmacovigilance

Risk management

Aggregate safety reports

Regulatory knowledge

Communication skills

Education

MD or PharmD

Tools

Excel

Word

PowerPoint

Job description

Servier is seeking a Director, Global Safety Lead to lead safety and risk management for development and marketed compounds. The role collaborates with Boston and Suresnes teams in a global safety organization.

The candidate will oversee medical review, signal detection, safety reporting, and regulatory interactions while guiding safety strategy and compliance across phases and markets. Hybrid Boston-based role with occasional travel.