The Role:

Reporting to the Senior Medical Director, Pharmacovigilance, the Associate Medical Director, Drug Safety and Pharmacovigilance is responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be 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, PSUR and clinical safety assessments). 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:

• 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

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 orientated, 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:

• 4+ years’ experience in Drug Safety / Pharmacovigilance in a Biotech / Pharma company
• 8+ years of industry (Biotech / Pharma) experience
• 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)
• 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
• Excellent verbal, written and presentation skills