Nuvalent is seeking an Associate Director, Pharmacovigilance (PV) Operations to manage vendor oversight and review of ICSR processing, ensuring compliance and adherence to Safety processes and SOPs. The role will also involve managing and analyzing data from the Global Safety Database, and working in close collaboration with PV physicians, PV scientists, and PV Excellence on operational safety and case quality issues.
Requirements
- Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities.
- Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans.
- Monitor performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; provide appropriate feedback and training.
- Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders.
- Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
- As needed, review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports.
- Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team.
- Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines.
- Serve as PV operations SME on safety reporting processes according to study protocol.
- Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
- Serve as resource and contact for other functions within the company for pharmacovigilance operational activities.
- Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement savings plan
- Generous paid time off
