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. The role involves overseeing pharmacovigilance processes, ensuring regulatory compliance, and providing expert medical guidance across clinical projects.

Key responsibilities

• Maintain accurate recording of project time, expenses, and travel, and ensure delegated pharmacovigilance tasks are executed correctly.
• Adhere to applicable regulations and ICH guidelines for clinical trials, regulatory documents, and safety issues.
• Provide medical consultation, answer study‑related medical questions, and deliver safety‑reporting training.
• Medically review adverse events, serious adverse events, and events of special interest from all sources.
• Perform data review, coding validation, and safety data assessment as defined in client contracts.
• Assist in drafting and reviewing CSR, IND/NDA, ICSR, signal detection reports, periodic safety reports, RMP, REMS, and CTD modules.
• Manage signal detection activities, contribute to label updates, and support dossier maintenance and risk‑management activities.

Required profile

• MD or equivalent qualification; active medical license preferred.
• Minimum 2 years of clinical experience with diagnostic and treatment responsibility, or 3 years of pharmacovigilance/medical safety review experience.
• Fluent in spoken and written English.
• General medical knowledge across multiple specialties; therapeutic expertise in at least one specialty is a plus.

Required skills

• Working knowledge of FDA, ICH, EMA regulations and GCP guidelines.
• Understanding of basic biostatistics, data management, and clinical operations procedures.
• Experience with pharmacovigilance processes and adverse event review.