About the role
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
Excellent oral and written communication skills for effectively interfacing with vendors and internal stakeholders
Fosters strong relationships and values collaboration to develop and execute on plans
Ability to multi-task in a fast-paced environment
Self-motivated, conscientious, and enthusiastic about curing human diseases
Other Required:
Experience with case processing in ARGUS
Experience of Analysis of Similar Events (AoSE) and patient safety narratives
Demonstrated ability to challenge existing practices to become more effective.
Ability to effectively adapt to a variety of situations.
Meet quality and performance standards.
Strong influencing skills
Excellent communication skills, both written and oral
Work effectively as a team member and promotes collaboration.
Demonstrate ownership, initiative and accountability.
Less than 20% travel.
Competencies:
Ability to deliver on commitments and understanding of service culture.
Communicates effectively and efficiently on safety issues to internal and external stakeholders.
Maintain consistency of safety assessments.
Serve in cross-functional teams as Drug Safety expert.
Monitor regulatory compliance of safety reporting throughout trial.
Lead and contribute to process development and/or process improvements that support Drug Safety
Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.
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