Pharmacovigilance Case Processing Manager

About the role

Servier is a Boston‑based biopharmaceutical company seeking a manager to oversee end‑to‑end pharmacovigilance case processing outsourced to a vendor. The role collaborates with internal safety teams, external vendors and cross‑functional groups to ensure compliant, high‑quality case management.

Key responsibilities

• Manage pre‑ and post‑marketing pharmacovigilance cases processed by an external service provider, including book‑in, data entry, coding, narratives, quality control, medical review and regulatory submission.
• Perform weekly quality control of vendor‑processed cases, draft deviation forms, conduct root‑cause analysis and implement CAPAs for late submissions.
• Review clinical trial protocols and eCRFs, write Safety Management Plans, and request updates to ARGUS database configurations.
• Coordinate reconciliation with local pharmacovigilance teams, participate in study kick‑off and operational meetings, and act as SME during audits and inspections.

Required profile

• Bachelor’s degree in Life Sciences or PharmD, preferably a healthcare professional.
• Minimum 4 years of pharmacovigilance case management experience with investigational or approved products.
• Strong knowledge of international PV regulations, safety reporting requirements and literature review for signal detection.
• Hands‑on experience with safety databases such as ARGUS and other safety information systems.

Required skills

• Pharmacovigilance case processing and quality control.
• CAPA management and root‑cause analysis.
• Vendor performance monitoring and training.
• KPI development and monitoring for case processing activities.

What we offer

• Salary range $131,000–$150,000 plus short‑term and long‑term incentive programs.
• Comprehensive benefits including medical, dental, vision, unlimited sick and flex time, 401(k), life and disability insurance.
• Hybrid work model (2–3 days onsite in Boston) with occasional travel to the France headquarters.