Associate Medical Director, Drug Safety and Pharmacovigilance Expert

3 weeks ago

Cambridge, Massachusetts, United States Nuvalent, Inc. Full time
The Role: As a key member of the Nuvalent team, the Associate Medical Director, Drug Safety and Pharmacovigilance will be responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. This includes assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. The successful candidate will provide interpretation and summaries of drug safety information and contribute to the generation of safety reports, such as DSURs, PSURs, and clinical safety assessments.

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, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements
  • Support 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, ensuring 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, and investigator brochures
  • Provide medical safety input into the development of Reference Safety Information
  • Contribute to the creation or updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents
  • 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 communities
  • Collaborate with Medical Directors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trials
  • 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
Competencies Include:
  • Strong written/verbal communication skills
  • Ability to work in a collaborative environment and build effective working relationships across the organization, and with external stakeholders/vendors
  • Detail and process-oriented, with excellent project management, problem-solving, and organization skills
  • Ability to think critically with strong attention to detail
  • Demonstrated project management and prioritization capabilities
Qualifications:
  • 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, 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)
  • 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

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