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Precision for Medicine is seeking an experienced Drug Safety Physician to lead the pharmacovigilance function for a biotech company focused on precision oncology. This is a remote role available to candidates based in the UK, Hungary, Romania, Serbia, or Slovakia.
The Drug Safety Physician will be responsible for all aspects of drug safety and pharmacovigilance, including medical review and oversight of safety event processing, clinical trial Serious Adverse Event (SAE) handling, and safety data analysis to support signal detection and risk/benefit evaluation. The role ensures timely, consistent, and accurate safety reporting in accordance with FDA, EMA, ICH guidelines, and Good Clinical Practice standards.
Key responsibilities include:
- Managing all aspects of drug safety and pharmacovigilance, including leadership of safety data review, signal detection, and risk communication
- Providing medical and drug safety expertise for risk-benefit assessment, clinical trial data interpretation, and medical review of individual SAE case reports
- Collaborating with CRO Safety Physicians, Medical Directors, and Clinical Scientists on safety monitoring, assessment, and reporting activities
- Contributing to safety sections in cross-functional documents (protocols, study reports, Investigator's Brochures, Informed Consent Forms) and responding to safety-related regulatory inquiries
- Serving as the accountable point of contact for setting up and running Data Safety Monitoring Boards (DSMBs) and safety data review meetings
- Participating in routine safety cohort reviews for Phase 1 dose escalation studies
- Performing event coding review and clinical/safety database reconciliation
- Overseeing drug safety systems to ensure compliance with safety data management and reporting requirements across all relevant territories
- Ensuring effective standard operating procedures and strong safety vendor governance
- Recommending and planning for future development of drug safety and pharmacovigilance capabilities to support regulatory filings and commercialization, including acquiring Qualified Person for Pharmacovigilance (QPPV) support and participating in Risk Management Plans and Pharmacovigilance System Master Files
- Maintaining audit and inspection readiness of the function
The company combines deep science with advanced technological platforms and specialized expertise in designing and executing targeted, adaptive clinical trials in oncology.
REQUIREMENTS:
- MD required with a minimum of 7 years in drug safety-related activities in pharma/biotech
- Clinical trial experience, including oncology drug safety, with at least 3 years in early clinical development
- Experience authoring, reviewing, and providing input to drug safety-related regulatory reports
- Successful involvement in regulatory agency interactions or inspections
- Strong knowledge of FDA, EU, ICH, and other global regulatory requirements for safety reporting and risk management
- Solid medical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring
- Proficiency with standard computer applications (Microsoft Office, Windows) and safety databases
- Experience with case processing in ARGUS
- Experience with Analysis of Similar Events (AoSE) and patient safety narratives
- Excellent oral and written communication skills
- Ability to work effectively in cross-functional teams and foster collaboration
- Demonstrated ability to challenge existing practices and adapt to various situations
- Strong influencing skills and sense of urgency
- Less than 20% travel required
