Associate Medical Director, Drug Safety and Pharmacovigilance

Summary

Join Nuvalent, a dynamic early-stage company focused on developing cancer treatments, as an Associate Medical Director, Drug Safety and Pharmacovigilance. Reporting to the Senior Medical Director, Pharmacovigilance, you will be responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. You will interpret safety data from various sources, contribute to safety reports, collaborate with internal and external teams, and maintain up-to-date knowledge of drug safety regulations. This role requires a strong medical background and significant experience in drug safety and pharmacovigilance. The ideal candidate will possess excellent communication and collaboration skills, along with a proven track record in medical drug safety assessments and report generation.

Requirements

• 4+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
• Healthcare degree required / Medical Degree (MD) from recognized medical school preferred
• 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)
• 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
• Excellent verbal, written and presentation skills

Responsibilities

• Provide medical expertise in the assessment of ICSRs
• Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports
• Contribute to 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 clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs) and 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) and the maintenance of these documents
• Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents
• Provide safety and pharmacovigilance training programs as required
• Collaborate cross functionally (e.g. Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input
• Support other pharmacovigilance and drug safety responsibilities as assigned

Preferred Qualifications

• 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