Executive Medical Director, Drug Safety

Reporting to the SVP, Global PV & Risk Management, the Executive Medical Director will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PSUR and clinical safety assessments).

The individual will manage a group of medical safety professionals and PV scientists that will closely collaborate internally with other functions (e.g., Clinical Operations, Regulatory Affairs, Biostatistics, Clinical Development, and other Program Teams) and Contract Research Organizations (CROs) and Collaboration partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

• Manage team of medical professionals and PV Scientists
• Provide medical expertise/guidance in the assessment of ICSRs and aggregate drug safety reports
• Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports
• Contribute to and Oversight of signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals
• Serve as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and Reference Safety Information (RSI)
• Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents
• Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
• Contribute to safety and pharmacovigilance training programs. Provide safety training at investigator meetings
• Collaborate with Medical Monitors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trials
• Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services
• Provides strategic planning, implementation, and management of drug safety activities to support clinical development pipeline.
• Lead role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
• Manages internal staff and external contractors to ensure delivery of quality safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function.
• The role will require some travel (approximately 10-15%), and hiring and managing people

• Medical Degree (MD) from recognized medical school with medical practice experience
• 8+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
• Experience in managing Medical Professionals and PV Scientists
• Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
• Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities
• Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
• Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment)
• Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER)
• Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory…