Drug Safety Physician – Pharmacovigilance Lead

About the role

Precision Medicine is hiring an experienced Drug Safety Physician to join its team. The role leads the pharmacovigilance function, overseeing medical review and processing of all safety events across clinical programs.

Key responsibilities

• Lead drug safety and pharmacovigilance activities, including safety data review, signal detection, risk communication and mitigation.
• Provide medical expertise for risk‑benefit assessments, clinical trial SAE review, and safety data interpretation.
• Collaborate with CRO safety physicians, medical directors and clinical scientists on case and aggregate safety reporting.
• Set up and run DSMBs or safety data review meetings and participate in Phase 1 dose‑escalation cohort reviews.
• Oversee drug safety systems, ensure SOP compliance, vendor governance and audit readiness.

Required profile

• Medical Doctor (MD) with a minimum of 7 years experience in drug safety within pharma/biotech.
• At least 3 years of oncology drug safety experience in early clinical development.
• Proven experience authoring regulatory safety reports and interacting with health authorities.
• Strong knowledge of FDA, EMA, ICH and global safety reporting requirements.

Required skills

• Case processing in ARGUS.
• Analysis of Similar Events (AoSE) and patient safety narratives.
• Proficiency with safety databases and Microsoft Office/Windows applications.