Executive Vice President, PV Operations

Executive Vice President, PV Operations

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 will manage PV teams, optimize operational processes, and collaborate cross-functionally to ensure the highest level of patient safety and product quality. They will be focused on ensuring we optimize the cost, speed, and quality of delivery through leveraging metrics to inform management interventions.

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 overall objectives.
• Development and implementation of strategic plans for the expansion of the Safety and Pharmacovigilance services in terms of revenue, operational margins and resources
• Lead, mentor, and develop PV operational teams, fostering a culture of accountability, high performance, and continuous learning.
• Partner with the Enterprise PMO/BPO to realize the objectives of the value creation plan (VCP)
• Represent PV operations at senior/executive management meetings, governance boards, and cross-functional leadership forums.
• Accurately forecast future needs and allocate resources accordingly.
• Define KPIs and monitor team performance

Operational Excellence

• Champion a culture of excellence across global PV operations, embedding best practices, innovation, and continuous improvement to enhance patient safety outcomes.
• Collaborate with Enterprise PMO/BPO to optimize and standardize end-to-end pharmacovigilance process, ensuring efficient, compliant, and high-quality execution of PV project management, case processing and literature, medical scientific affairs, PV regulatory and PV medical information.
• Optimize operational frameworks by streamlining workflows, leveraging automation, and integrating emerging technologies to improve data accuracy, reporting timeliness, and decision-making speed.
• Identify "optional" process variation and engage with commercial leadership to ensure we maximize revenue for these options.
• Collaborate with Enterprise PMO/BPO to and monitor KPIs and performance dashboards to proactively track operational efficiency, compliance metrics, and signal detection performance.
• Drive global harmonization of PV processes across regions, affiliates, and partners to ensure consistent execution and regulatory alignment.
• Lead inspection readiness and quality excellence initiatives, ensuring that PV systems, documentation, and processes exceed regulatory expectations and withstand scrutiny from health authorities.
• Foster cross-functional collaboration with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development to integrate safety insights into strategic 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 realize the objectives of the value creation plan (VCP)
• Collaborate with Enterprise PMO/BPO to lead the transformation of PV processes through the adoption of automation, advanced analytics, and AI-driven solutions to enhance efficiency, accuracy, and scalability.
• Streamline workflows and eliminate redundancies to optimize resource allocation, reduce cycle times, and strengthen safety data quality.
• Leverage industry benchmarking and best practices to identify and implement process enhancements that drive competitive advantage.
• Implement robust change management strategies to ensure successful integration of new tools, systems, and methodologies across global PV teams and partners.
• Engage with Enterprise PMO/BPO to ensure adherence to corporate governance for the initiation of new and ongoing change initiatives.

Cross-Functional Collaboration

• Act as a strategic bridge between Pharmacovigilance Operations and key internal stakeholders, ensuring safety intelligence informs and enhances corporate decision-making across the product lifecycle.
• Embed PV insights into strategic business planning, ensuring that patient safety, compliance, and benefit–risk considerations are central to portfolio management and market expansion decisions.
• Facilitate global alignment by harmonizing safety processes and communications between affiliates, regional offices, and headquarters.
• Contribute to cross-functional governance committees and safety boards, providing expert safety input for product development, launch readiness, and lifecycle management.
• Promote a culture of shared accountability for patient safety, enabling cross-departmental ownership of pharmacovigilance excellence.

Qualifications:

• Ideally an Advanced degree
• 15 + years of pharmacovigilance experience, with at least 10 years in an operational leadership role with P&L responsibilities.
• In-depth knowledge of global PV regulations, GVP modules, and drug safety principles.
• Proven track record of managing PV operations in a global environment within a CRO or PV service provider.
• Strong leadership, project management, and strategic thinking skills.
• Excellent communication, negotiation, and interpersonal abilities.
• Experience with safety databases (e.g., Argus, ArisG) and PV software tools.
• Strategic leadership and decision-making
• Operational excellence and process improvement
• Regulatory compliance and risk management
• Cross-functional collaboration
• High attention to detail and analytical skills

Additional Information:

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow.

We offer:

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.