Associate Director, Drug Safety And Pharmacovigilance Operations

Summary

Join Nuvalent, a dynamic early-stage company in the oncology drug development field, as the Associate Director of PV Operations. Reporting to the Senior Director of Pharmacovigilance (PV) Operations, you will oversee PV's role in expanded and early access programs (EAPs), manage vendor relationships, ensure safety data compliance, and serve as a subject matter expert. This role involves adverse event reconciliation, regulatory reporting, risk identification, and collaboration with internal and external stakeholders. As Nuvalent grows, this position will evolve alongside the company's expansion towards market authorization. The ideal candidate will possess extensive experience in pharmacovigilance operations within the biotech/pharmaceutical industry and a strong understanding of relevant regulations.

Requirements

• Bachelor’s degree in a relevant field or related experience
• 8+ years of relevant experience within the biotechnology or pharmaceutical industry, including, 4+ years of experience in Pharmacovigilance operations
• Hands-on expert knowledge of Argus or equivalent PV database
• Ability to interpret and follow regulatory guidelines
• Proven knowledge of Good Documentation Practices and cGXPs
• Basic knowledge of MedDRA coding
• Experience in ICSR case-processing and reporting
• Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
• Expert knowledge of pharmacovigilance activities and processes, preferably in multiple PV functional areas
• Direct experience managing relationships with service providers or external business partners

Responsibilities

• Oversight of EAP vendor, including, but not limited to, safety data exchange agreement maintenance and compliance monitoring
• Adverse event reconciliation between databases
• Oversight of safety reporting requirements for all EAP countries
• Primary point of contact for PV requests within the EAPs
• Support PV Operations team activities to ensure cross coverage across the portfolio
• Support regulatory inspections and serve as subject matter expert on PV’s role in EAPs
• Identify potential risks and opportunities within the EAPs, keeping PV Leadership informed for proactive decision-making

Preferred Qualifications

• Excellent oral and written communication skills with high emotional intelligence
• Track record of effective decision-making and conflict management/resolution 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, effectively communicating verbally and in writing
• Demonstrated project management and prioritization capabilities