Medical Director M‑SERM

About the role

We are seeking a Medical Director to lead our M‑SERM (Medical Safety Evaluation and Risk Management) activities. The role involves overseeing pharmacovigilance processes, providing medical expertise to project teams, and ensuring compliance with regulatory standards.

Key responsibilities

• Maintain accurate records of project time, expenses, and travel.
• Ensure delegated tasks to the PVG team are executed correctly.
• Apply FDA, ICH, EMA, and GCP guidelines to clinical trial safety and regulatory documents.
• Provide medical consultation and answer 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 review, coding validation, and assess potential safety concerns.
• Assist in drafting and reviewing CSR, IND/NDA, ICSR, signal detection, periodic safety, RMP, REMS, and CTD modules.
• Manage signal detection activities, support label updates, and contribute to risk management dossiers.

Required profile

• MD or equivalent; active medical license preferred.
• Minimum 2 years of clinical experience with diagnostic and treatment responsibility, or 3 years in medical review/pharmacovigilance.
• Fluent in spoken and written English.
• Broad medical knowledge across multiple specialties; therapeutic expertise in at least one specialty is a plus.
• Strong decision‑making, problem‑solving, and analytical abilities.
• Excellent oral and written communication and interpersonal skills.
• Understanding of basic biostatistics, data management, and clinical operations.

Required skills

• FDA guidelines
• ICH guidelines
• EMA guidelines
• Good Clinical Practice (GCP)
• Biostatistics