Safety Physician

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 risks

Provide 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 SAEs

Work 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 Committees

Act as the point of contact accountable for setting up and running DSMBs or safety data review meetings

Participate in routine safety cohort reviews for ongoing Phase 1 dose escalation studies

Perform event coding review and clinical & safety database reconciliation for consistent coding

Oversee and manage Drug Safety system(s) to ensure compliance with safety data management and reporting requirements in all relevant territories and optimized safety database ownership and access for safety monitoring, signal detection and reporting

Ensure effective SOPs and strong safety vendor governance are in place

Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File

Ensure audit and inspection readiness of the function at all times

Education and Skills Required:

MD required, with a minimum of 7 years in Drug Safety related activities in pharma/biotech

Clinical trial experience, including oncology drug safety with least 3 years being 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 safety data and risk management

Solid medical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring

Proficiency with using standard computer applications (eg Microsoft Office, Windows) and safety databases

Possesses a sense of urgency and an ability to anticipate and respond quickly to emerging information