Medical Director M‑SERM

About the role

PPD is seeking a Medical Director M‑SERM to lead medical safety evaluation and risk management activities across its clinical programs. The role involves providing expert medical consultation, overseeing adverse event review, and ensuring compliance with regulatory standards.

Key responsibilities

• Review and medically assess adverse events, serious adverse events, and events of special interest from all data sources.
• Conduct signal detection, periodic safety reporting, and contribute to label updates and risk management plans.
• Prepare and review safety-related regulatory documents such as CSR, IND/NDA reports, ICSR, RMP, REMS, and CTD modules.
• Provide safety reporting training and support to project teams.
• Ensure adherence to client SOPs, PPD corporate policies, and applicable FDA, ICH, EMA, and GCP guidelines.

Required profile

• MD or equivalent with an active medical license (preferred).
• Minimum 2 years of clinical experience with diagnostic and treatment responsibility, or 3 years in pharmacovigilance/medical safety review.
• Fluent in spoken and written English.
• Strong decision‑making, analytical, and communication skills.

Required skills

• Pharmacovigilance and adverse event review.
• Signal detection and risk management.
• Medical writing for safety documents.
• Working knowledge of FDA, ICH, EMA, and GCP guidelines.
• Basic biostatistics, data management, and clinical operations.