Medical Director – Medical Safety Evaluation & Risk Management

About the role

We are seeking a Medical Director to lead our Medical Safety Evaluation and Risk Management (M‑SERM) activities. You will provide expert medical oversight for pharmacovigilance projects, ensure regulatory compliance, and support safety reporting across clinical studies.

Key responsibilities

• Maintain accurate time‑tracking, expense, and travel records for project and administrative tasks.
• Oversee delegated pharmacovigilance tasks to ensure proper execution.
• Apply FDA, ICH, EMA, and GCP guidelines to clinical trial safety documentation.
• Provide medical consultation to project teams and answer all study‑related medical questions.
• Deliver safety‑reporting training and conduct medical review of adverse events, serious adverse events, and events of special interest.
• Perform 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.
• Support label updates, dossier maintenance, and overall risk‑management activities.

Required profile

• MD or equivalent medical degree; active medical license preferred.
• Minimum 2 years of clinical experience with diagnostic and treatment responsibility, or 3 years in medical review/pharmacovigilance.
• Fluent spoken and written English.
• Strong knowledge of diagnostic and therapeutic approaches across multiple specialties.

Required skills

• Pharmacovigilance and safety data review.
• Medical writing for regulatory submissions (CSR, IND/NDA, RMP, etc.).
• Working knowledge of FDA, ICH, EMA, and GCP guidelines.
• Signal detection and periodic safety reporting.
• Basic biostatistics, data management, and clinical operations procedures.

What we offer

• Opportunity to lead high‑impact safety projects in a collaborative environment.
• Access to cutting‑edge medical and regulatory resources.