Associate Director, Pharmacovigilance (PV) Operations

Job description

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 Senior Director of Pharmacovigilance (PV) Operations, the Associate Director of PV Operations will provide vendor oversight and review of ICSR processing. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be the primary point of contact for quality oversight of the case processing vendor. They will work in close collaboration with PV physicians, PV scientists, and PV Excellence on operational safety and case quality issues The role will expand and evolve in line with Nuvalent’s expansion as we approach potential market authorization. Responsibilities : - Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities. - Pr...