Senior Pharmacovigilance Physician (MD)

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer.  Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 

The Role:

Reporting to the Chief Medical Officer, you will be a key contributor to the Nuvalent development team.  This physician will be responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and be the subject matter expert on drug safety information. You will monitor and assess safety data from clinical trials to characterize the safety profile of Nuvalent medicines, and work with other development team leaders to develop and implement risk mitigation processes, as required. This physician will provide summaries and interpretation of safety information for periodic and ad hoc safety reports (e.g., DSURs, RA queries, IRB request for information, and clinical safety assessments). You will serve as an integral member of the cross-functional development team, at the clinical trial and program level.   Working with Contract Research Organizations (CROs), you will develop and implement scalable “best practice” processes and will ensure regulatory compliance for all cases and required deliverables. You have the medical knowledge and clinical experience to manage patient safety and have a strong knowledge of regulatory requirements. You have broad knowledge of pharmacovigilance group structure and day-to-day function as well as people management experience and the potential to grow into a senior leadership role within the company.

Responsibilities:

• Maintain regulatory reporting compliance for expedited cases and required aggregate safety reports.
• Provide medical review in the assessment of ICSRs, including query evaluation and input.
• Key contributor in creation of development safety update report and investigator brochures (IBs)
• Review and provide input to Safety- and PV- related aspects of clinical trial protocols and informed consent documents.
• Provide medical input/review of new or existing safety documents to ensure compliance with relevant regulatory requirements, including protocols, safety summaries and regulatory reports.
• Provide medical guidance and support to internal PV operations.
• Lead safety surveillance & detection activities, including signal identification and management.
• Serve as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and other clinical documents as required.
• Develop and/or provide PV-related input to Standard Operating Procedures, Working Instructions, and other documentation.
• Work in a cross-functional setting with Medical Directors and Clinical Research Scientists, and vendor clinical staff who provide medical monitoring support for ongoing clinical trials.
  
  

Competencies:

• Excellent communications skills (verbal, written, presentation, etc.) —the ability to articulate, influence, and work successfully with varied audiences (colleagues, external partners, etc.)
• Adjusts easily to change, learns quickly, and understands how internal and external factors impact decisions
• Demonstrated ability to understand needs and align stakeholders, influence decisions and
• develop roadmaps and project plans to meet business needs
• Ability to work productively and build relationships in a fast-paced, results-driven, highly accountable environment where you can demonstrate initiative and make a clear impact

Qualifications: 

• 3-5 years of experience in Safety and Pharmacovigilance as part of a pharmaceutical or biotech company, CRO or regulatory agency.
• Experience in Oncology therapeutic area is preferred.
• Direct people management experience preferred.
• Medical Degree (MD) from recognized medical school with at least 2 years of medical practice experience. Board certification preferred.
• Strong understanding of US and EU drug safety regulations, CIOMS and ICH guidelines.
• Experience with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation of Analysis of Similar Event and company comment statements.
• Signal detection and analysis experience from clinical trials and other sources.
• Preparation of aggregate reports (DSUR, PSUR/PBRER, PADER).
• Experience and proficiency preparing responses to Regulatory Authorities.
• Experience with developing and updating Reference Safety Information.
• K