Remote Associate Medical Director, Drug Safety and Pharmacovigilance

Summary

Join a dynamic early-stage company working to create selective medicines for cancer patients and contribute to the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information.

Requirements

• 2+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
• Medical Degree (MD) with medical practice experience
• 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
• 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 Authorities as part of marketing approval
• Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels
• Ability to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholders
• Experience with MedDRA coding, Points to Consider, AoSE, and SMQs

Responsibilities

• Review, analyze, and compile safety data, and present the results
• Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports
• Support of the internal PV Operations function
• Contribute to ongoing safety surveillance and signal detection efforts, including the identification of safety observations, emergent safety concerns and new safety signals
• Serve as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs)
• Provide medical safety input into the development of Reference Safety Information
• Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS)
• Provide medical safety and Pharmacovigilance expertise in-house and by consultation with outside vendors for all development programs
• 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
• Present safety data and results
• Collaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community
• Develop relationships with and capture drug safety information from key groups, including partner companies, physicians, nurses and patient advocacy groups
• Serve as a subject matter expert for vendors providing drug safety and pharmacovigilance services