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 physician 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:

• 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, such as protocols, safety summaries and regulatory reports
• Support of 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, 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)
• Provide medical safety input into 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
• 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 community
• 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 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:

• 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