Regional Director in General Insurance driving strategy and P&L management for Everywhen across the South of England.
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)
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