Executive Vice President, Pharmacovigilance Operations

Overview

Prime Vigilance (part of Ergomed Group) is a specialised pharmacovigilance service provider established in 2008 with global teams across Europe, North America and Asia. The Executive VP, Pharmacovigilance (PV) Operations is responsible for leading and overseeing all operational aspects of global pharmacovigilance activities, ensuring compliance with regulatory requirements, company SOPs, and industry standards. This role manages PV teams, optimizes operational processes, and collaborates cross-functionally to ensure the highest level of patient safety and product quality, focusing on cost, speed and quality of delivery through leveraging metrics to inform management interventions.

We are committed to investing in staff through training and development, prioritising employee well-being and work-life balance to support high-quality client service. This role supports the journey to make a positive impact on patients’ lives.

• Leadership & Strategy
  • Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations.
  • Develop comprehensive operational strategies that align with the company’s long-term objectives and ensure goals are met through efficient processes.
  • Develop and implement strategic plans for expanding Safety and Pharmacovigilance services in terms of revenue, margins and resources.
  • Lead, mentor, and develop PV operational teams, fostering accountability, high performance, and continuous learning.
  • Partner with Enterprise PMO/BPO to realise the objectives of the value creation plan (VCP).
  • Represent PV operations at senior/executive management meetings, governance boards, and cross-functional leadership forums.
  • Forecast future needs and allocate resources accordingly to plan upcoming projects and optimise resource use.
  • Define KPIs and monitor team performance.
• Operational Excellence
  • Champion a culture of excellence across global PV operations, embedding best practices and continuous improvement to enhance patient safety outcomes.
  • Collaborate with Enterprise PMO/BPO to optimise and standardise end-to-end PV processes, including project management, case processing, literature, medical information, PV regulatory and PV medical information.
  • Streamline workflows, leverage automation, and integrate technologies to improve data accuracy, timeliness and decision-making speed.
  • Identify optional process variations and engage with commercial leadership to maximise revenue for these options.
  • Monitor KPIs and performance dashboards to proactively track operational efficiency, compliance metrics, and signal detection performance.
  • Drive global harmonisation of PV processes across regions, affiliates, and partners to ensure regulatory alignment.
  • Lead inspection readiness and quality excellence initiatives to exceed regulatory expectations and withstand health authority scrutiny.
  • Foster cross-functional collaboration with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development to integrate safety insights into product lifecycle management.
• Process Improvement & Innovation
  • Drive operational excellence through process mapping, automation and technology adoption.
  • Evaluate and implement advanced PV tools, AI-supported case processing, and process efficiencies.
  • Lead change management initiatives to adapt PV operations to evolving regulatory and organizational needs.
  • Partner with the Enterprise PMO to realise the objectives of the value creation plan (VCP).
  • Collaborate with Enterprise PMO/BPO to lead PV process transformation through automation, advanced analytics and AI-driven solutions to enhance efficiency, accuracy and scalability.
  • Streamline workflows, eliminate redundancies, optimise resource allocation and reduce cycle times.
  • Leverage industry benchmarking and best practices to identify and implement process enhancements for competitive advantage.
  • Implement robust change management strategies for integrating new tools, systems and methodologies across global PV teams and partners.
  • Engage with Enterprise PMO/BPO to ensure adherence to corporate governance for initiating new and ongoing changes.
• Cross-Functional Collaboration
  • Act as a strategic bridge…