Precision for Medicine is hiring an experienced Drug Safety Physician to join our team. Candidates can be based in the UK, Hungary, Poland, Romania, Serbia or Slovakia.Position Summary:The Drug Safety Physician will be responsible for the pharmacovigilance function, including medical review and oversight of processing for all types of safety events. The individual will provide clinical support of drug safety data management and interpretation and risk management activities for the company, including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs).Responsibilities (including but not limited to):Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection,



risk communication including safety information updates, and mitigation of potential risksProvide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of SAEsWork with CRO Safety Physicians/Team and Dragonfly’s Medical Directors, Clinical Scientists and other functions on safety monitoring, assessment and reporting activities (case and aggregate)Input on safety sections in cross-functional documents (eg, study protocols, study reports, IBs, ICFs) and on responses to safety-related questions from regulatory agency, IRBs and Ethics CommitteesAct as the point of contact accountable for setting up and running DSMBs or safety data review meetingsParticipate in routine safety cohort reviews for ongoing Phase 1 dose escalation studiesPerform event coding review and clinical & safety database reconciliat

📌 Safety Physician (España)
🏢 Precision Medicine Group
📍 España