Safety Physician

About the role

Precision for Medicine is seeking an experienced Drug Safety Physician to lead its pharmacovigilance function. The role involves medical review, safety data oversight, and risk management across clinical trials and regulatory submissions.

Key responsibilities

• Lead all aspects of drug safety and pharmacovigilance, including safety data review, signal detection, and risk communication.
• Provide medical expertise for risk‑benefit assessment, clinical trial data interpretation, and SAE case review.
• Collaborate with CRO safety teams, medical directors, and clinical scientists on safety monitoring, assessment, and reporting.
• Contribute safety sections to cross‑functional documents such as protocols, study reports, IBs, and ICFs.
• Organise and chair DSMBs or safety data review meetings.
• Perform event coding review and ensure consistent clinical and safety database reconciliation.
• Oversee drug safety systems to maintain compliance with FDA, EMA, ICH, and GCP requirements.
• Maintain SOPs, vendor governance, and audit/inspection readiness.
• Plan future development of pharmacovigilance capabilities, including QPPV support and risk management plan creation.

Required profile

• Medical Doctor (MD) degree.
• Minimum 7 years of drug safety experience in pharma/biotech.
• Clinical trial experience, preferably in oncology, with at least 3 years in early clinical development.
• Proven experience authoring and reviewing drug‑safety regulatory documents.

Required skills

• Deep knowledge of pharmacovigilance regulations (FDA, EMA, ICH, GCP).
• Expertise in safety data review, signal detection, and risk management.
• Experience with safety database management and event coding.
• Ability to lead safety teams and coordinate DSMB meetings.