Director, Global Safety Lead

$195,458 - $289,576/Yr

Servier Pharmaceuticals - Boston, MA

Full-time - Senior

Remote - Boston, MA

Professional, Scientific, and Technical Services

About the position

The Director, Global Safety Lead at Servier is responsible for overseeing safety and risk management activities for both development and marketed compounds. This role involves contributing to medical reviews, drug safety activities, signal detection, and regulatory filings, ensuring compliance with internal procedures and regulatory guidelines. The position requires a strong background in safety science and the ability to coordinate safety evaluations and reports, while also representing the Medical Safety Division in various project teams.

Responsibilities

• Contribute to safety and risk management activities of assigned development or marketed compounds.
• Conduct medical reviews and drug safety activities associated with clinical development, signal detection, and evaluation.
• Coordinate signal detection activities, including planning and safety data analysis.
• Generate aggregated safety reports for development and marketed compounds, including PBRER, PSUR, and DSUR.
• Review and generate safety sections of various documents such as protocols and clinical study reports.
• Contribute to regulatory filings and respond to Health Authority queries.
• Support maintenance of safety sections of the Company Core Data Sheet and related documents.

Requirements

• Must have a Medical Doctor (MD) or Doctor of Pharmacy (PharmD) (or foreign equivalent).
• 7 years of experience as a safety physician/scientist.
• Experience with medical review and drug safety activities in clinical development and post-marketing settings.
• Experience with signal detection, aggregate report writing, and benefit-risk assessment.
• Experience with regulatory filings (NDA, sNDA, MAA) and Health Authority interactions.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Flexible time off (unlimited sick time and flex time)
• 401(k)
• Life insurance
• Disability insurance
• Recognition programs