Associate Director, Pharmacovigilance (PV) Operations (CT Focus)

The Associate Director, Pharmacovigilance (PV) Operations will provide vendor oversight and review of ICSR processing for assigned investigational products, ensuring compliance and adherence to Safety processes and SOPs. They will manage and analyze data from the Global Safety Database and work in close collaboration with PV physicians and PV scientists on operational safety and case quality issues.

Requirements

• Manage and support the relationship with safety vendor(s)
• Provide Sponsor oversight of operational safety responsibilities
• Participate in daily management, operational oversight and execution of operational safety tasks
• Review incoming adverse event reports and communications from vendors
• Oversee case workflow between safety vendor and Nuvalent Pharmacovigilance team
• Ensure safety case queries are resolved as per defined processes
• Serve as PV operations SME on safety reporting processes
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement savings plan
• Paid time off
• Summer and winter company shutdown