Senior Manager, Pharmacovigilance Operations Excellence - Remote

Overview

The Senior Manager, PV Operations Excellence is a key member of the pharmacovigilance team at Nuvalent, responsible for maintaining compliance with regulatory reporting and managing standard PV procedures.

In Short

• Support and develop GVP SOPs and strategies.
• Manage vendor audits and internal inspection procedures.
• Present GVP activities during regulatory inspections.
• Review and maintain the Pharmacovigilance Safety Master File.
• Identify and escalate critical GVP findings.
• Track Key DSPV Performance Indicators (KPIs).
• Initiate deviations and perform root cause analysis.
• Oversee generation and review of GVP documents.
• Consult on GVP regulations and guidelines.

Requirements

• Bachelor's degree in healthcare or life sciences.
• 6+ years of experience in biotechnology or pharmaceutical industry.
• Experience in PV quality and compliance (GVP).
• Knowledge of global regulations for safety and PV.
• Experience in compliance and quality management systems.

Benefits

• Equal employment opportunities.
• Collaborative work environment.
• Focus on patient impact.
• Continuous improvement culture.