Senior Manager, Pharmacovigilance PV Operations Excellence

Summary

Join Nuvalent's pharmacovigilance team as a Sr. Manager, PV Operations Excellence, reporting to the SVP of DSPV. You will be a key member responsible for maintaining PV compliance, regulatory reporting, safety data presentation, and managing PV procedures. Collaborate cross-functionally and with external safety teams. This role requires strong knowledge of drug safety and pharmacovigilance regulations and practices. You will support and develop GVP SOPs, strategies, and processes, and ensure compliance through audits and inspections. The ideal candidate will have a Bachelor's degree, 6+ years of relevant experience, and proven expertise in GVP quality and compliance.

Requirements

• Minimum Bachelor's degree required preferably in healthcare or life sciences or the equivalent combination of relevant education or professional experience
• 6+ years of relevant experience within the biotechnology or pharmaceutical industry, including at least one (1-2) years of PV quality and compliance experience (GVP)
• Developing Standard Operating Procedure (SOP) in GVP field
• Experience in compliance and quality management systems including developing procedures, deviation/CAPA management, management of KPIs, regulatory inspections, and PV audits
• Working knowledge and understanding of global regulations for safety and PV including FDA, EMA, and ICH guidelines
• Working knowledge of PV processes for individual case processing, signal detection and evaluation, aggregate safety reporting, regulatory intelligence, as well as clinical study safety management

Responsibilities

• Support/Develop GVP SOPs, strategies and processes, review & training of PV SOPs
• Support the GVP- vendor audit, internal audit, and inspection procedures and address GVP-audit observations
• Present the GVP activities during regulatory inspections
• Review and provide QA support for maintenance of PSMF and SDEA
• Identify and escalate critical GVP findings to DSPV Senior Management
• Track Key DSPV Performance Indicators (KPIs)
• Develop, manage, implement, and improve internal Quality Management System for DSPV
• Initiate deviations and CAPAs, perform investigations and root cause analysis
• Oversee generation and review of documents used in GVP activities
• Provide consultation in interpretation of GVP regulations/guidelines