Lead Medical Reviewer (Pharmacovigilance)

About the role

The Lead Medical Reviewer (MRL) oversees and contributes to product surveillance activities for client projects, ensuring compliance with regulatory requirements. Acting as a Subject Matter Expert in medical review and ICSR management, the MRL provides scientific input, authors key sections of pharmacovigilance (PV) documents, and supports cross‑functional teams.

Key responsibilities

• Support line managers in managing the medical review team and develop safety‑related presentation materials.
• Oversee adjudication, analysis, and quality assurance of signal detection outputs; improve signal evaluation tools.
• Lead signal management and benefit‑risk evaluation for aggregate safety reports (e.g., PBRER, PSUR/DSUR).
• Provide medical and PV leadership at safety meetings and serve as lead for multiple compounds.
• Author safety sections of clinical protocols, informed consents, reference safety information, and periodic reports.
• Supervise, train, and mentor junior safety scientists and other safety staff.
• Contribute to strategic advice, medical writing, and business development initiatives.

Required profile

• Board‑certified physician with extensive pharmacovigilance experience.
• Strong knowledge of regulatory requirements for safety reporting and risk management.
• Proven ability to lead cross‑functional teams and manage complex safety projects.
• Excellent problem‑solving skills and a proactive, quality‑driven approach.

Required skills