Medical Director – Medical Safety & Risk Management

About the role

We are seeking a Medical Director to lead our Medical Safety Evaluation and Risk Management (M‑SERM) activities. The successful candidate will provide medical expertise across multiple therapeutic areas, ensure compliance with regulatory standards, and support the safety reporting process for clinical studies.

Key responsibilities

• Maintain accurate records of project time, expenses and travel.
• Oversee pharmacovigilance (PV) tasks and ensure proper execution of delegated activities.
• Apply FDA, ICH, EMA and GCP guidelines to clinical trial safety documentation.
• Provide medical consultation and answer study‑related medical questions.
• Conduct medical review of adverse events, serious adverse events and events of special interest from all data sources.
• Assist in drafting and reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic safety reports, RMP, REMS and CTD modules.
• Manage signal detection activities, support label updates and dossier maintenance.

Required profile

• MD or equivalent medical degree; active medical license preferred.
• At least 2 years of clinical experience with direct diagnostic and treatment responsibility, or 3 years in medical review/pharmacovigilance.
• Fluent written and spoken English.
• Strong decision‑making, problem‑solving and analytical abilities.

Required skills

• Working knowledge of FDA, ICH, EMA and GCP guidelines.
• Understanding of basic biostatistics, data management and clinical operations procedures.
• General medical knowledge across multiple specialties.