Medical Director – M‑SERM (Pharmacovigilance)

About the role

We are seeking a Medical Director to lead our M‑SERM program, focusing on medical safety evaluation and risk management across clinical trials. The role involves providing expert medical consultation, ensuring regulatory compliance, and guiding safety reporting activities.

Key responsibilities

• Maintain accurate time‑recording, expense, and travel documentation for project and administrative tasks.
• Oversee delegated pharmacovigilance activities to ensure proper execution.
• Apply FDA, ICH, EMA, and GCP guidelines to clinical trial safety and regulatory documents.
• Review adverse events, serious adverse events, and events of special interest from all data sources.
• Conduct data validation, coding review, and safety signal detection as defined in client contracts.
• Contribute to the preparation and review of CSR, IND/NDA, ICSR, signal detection reports, periodic safety reports, RMP, REMS, and CTD modules.
• Provide safety reporting training and maintain open communication with associates and clients.

Required profile

• MD or equivalent qualification; active medical license preferred.
• Minimum 2 years of clinical experience with diagnostic and treatment responsibility, or 3 years in medical review/pharmacovigilance.
• Strong decision‑making, analytical, and organizational abilities.
• Excellent oral and written communication skills in English.

Required skills

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