The Role:

Reporting to the Head of PV Science, the Associate Director, Drug Safety and Pharmacovigilance Scientist is responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This individual is expected to 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). This individual may also support the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be an integral part of a group of safety professionals within Nuvalent and will closely collaborate with safety teams in Contract Research Organizations (CROs) and 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.

Responsibilities:

• 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 processes, 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) 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 the medical assessment of ICSRs as needed
• Support other pharmacovigilance and drug safety responsibilities as assigned

Competencies Include:

• Design global risk management frameworks for Nuvalent’s medicines
• Translate safety data into clinical insights
• Adapt visualization tools for safety surveillance
• Influence multidisciplinary teams to prioritize patient safety.
• Strong ability to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholders

Qualifications:

• 4+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
• 7+ years of Pharma / CRO experience.
• 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