Safety Physician

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 (title commensurate with experience)
• 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
• 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.
• Supervisory experience
• 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