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Salary: PLN 340,080 - 511,200 / annual
Precision for Medicine is seeking an experienced Drug Safety Physician to lead the pharmacovigilance function for clinical trials in oncology. This is a senior individual contributor role responsible for medical review and oversight of all safety events, clinical trial Serious Adverse Event (SAE) processing, safety data analysis, signal detection, and risk/benefit profile 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 to enable risk-benefit assessment and clinical trial data interpretation
- Collaborating with CRO Safety Physicians, Medical Directors, and Clinical Scientists on safety monitoring and reporting activities
- Contributing to safety sections in study protocols, reports, Investigator's Brochures, and Informed Consent Forms
- Serving as point of contact for 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 territories
- Ensuring effective SOPs and strong safety vendor governance
- Recommending and planning future development of drug safety and pharmacovigilance capabilities, including Risk Management Plans and Pharmacovigilance System Master Files
- Maintaining audit and inspection readiness
The role is based remotely and can be located in the UK, Hungary, Poland, Romania, Serbia, or Slovakia. Travel is less than 20% annually.
REQUIREMENTS:
- MD required
- Minimum 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 hematology/oncology clinical trial concepts and terminology
- Proficiency with 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
- Self-motivated and conscientious with ability to multi-task in fast-paced environment
