Drug Safety Physician – Oncology Clinical Trials

About the role

Precision Medicine Group is seeking an experienced Drug Safety Physician to lead pharmacovigilance activities for oncology clinical programs. The role will oversee safety data review, signal detection, risk communication and regulatory reporting across multiple European sites.

Key responsibilities

• Lead all aspects of drug safety and pharmacovigilance, including case review, signal detection and risk mitigation.
• Provide medical expertise for safety monitoring, DSMB setup, and safety data review meetings.
• Oversee safety database management, ensure compliance with FDA, EMA and ICH guidelines, and maintain audit readiness.
• Collaborate with CRO safety physicians, medical directors and cross‑functional teams on safety sections of protocols, reports and regulatory submissions.

Required profile

• MD with minimum 7 years experience in drug safety, including oncology early‑phase clinical development.
• Proven track record authoring regulatory safety reports and interacting with health authorities.
• Strong knowledge of FDA, EU, ICH safety reporting requirements and risk management.

Required skills

• ARGUS case processing.
• Analysis of Similar Events (AoSE) and patient safety narrative preparation.
• Safety database management and reconciliation.
• Proficiency with Microsoft Office applications.
• Regulatory reporting and submission expertise.