Hybrid Associate Director, Drug Safety, Pharmacovigilance Scientist

at Nuvalent, Inc.

• Job title: Associate Director, Drug Safety, Pharmacovigilance Scientist
• Job type: Full Time
• Experience level: Senior
• Salary: $170,000 - $195,000 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Cambridge, United States

About the role

• Associate Director in Drug Safety and Pharmacovigilance at Nuvalent, assessing and interpreting safety data from multiple sources in the pharmaceutical industry.

Responsibilities

• Assess and interpret safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports
• Provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PADERs, PBRERs, and clinical safety assessments)
• Support the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information
• 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
• Contribute to signaling and safety surveillance processes, 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)
• Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS)
• Provide safety and pharmacovigilance training programs as required
• Collaborate cross functionally (e.g., Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input

Requirements

• 4+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
• Degree in a medical or healthcare related discipline like MD, PharmD, RN or PhD.
• Excellent knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
• Experience with medical drug safety assessments, drug safety surveillance and monitoring activities
• Experience with safety data collection and interpretation from clinical trials, literature and post market
• Experience with preparation of responses to Regulatory Authorities and 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, IB, Company Core Data Sheet and local labels
• Excellent verbal, written and presentation skills.

Benefits

• medical, dental, and vision insurance
• 401(k) retirement savings plan
• generous paid time off (including a summer and winter company shutdown)