Executive Vice President, Pharmacovigilance (PV) Operations
Employment Type: Full-time
Work Model: Remote
Department: PV Operations
Company: PrimeVigilance (Ergomed Group)
1. Company Overview
PrimeVigilance is a global pharmacovigilance service provider established in 2008, offering services in:
Medical Information
Pharmacovigilance
Regulatory Affairs
Quality Assurance
The company supports pharmaceutical and biotech partners worldwide across all therapeutic areas, including medical devices.
PrimeVigilance promotes employee development, mental well-being, and work–life balance as pillars of high-quality client service.
2. Role Summary
The Executive VP, PV Operations oversees all global pharmacovigilance operational activities, ensuring compliance, optimizing processes, and driving strategic growth.
The role focuses on cost, speed, and quality optimization through data-driven decision-making and leadership of global PV teams.
3. Key Responsibilities
A. Leadership & Strategy
Provide strategic direction aligned with corporate goals and regulatory requirements.
Develop long-term operational strategies to achieve business objectives.
Lead expansion of Safety & PV services related to revenue, operational margins, and resource planning.
Mentor and develop global PV teams; foster accountability and continuous learning.
Partner with Enterprise PMO/BPO to execute the Value Creation Plan (VCP).
Serve as senior PV representative in executive meetings and leadership forums.
Forecast future project and resource needs; allocate resources effectively.
Define and monitor KPIs to track global PV performance.
B. Operational Excellence
Champion best practices and continuous improvement across PV operations.
Standardize and optimize end-to-end PV processes (case processing, literature, regulatory, medical scientific affairs, MI).
Drive workflow automation, technology integration, and data accuracy improvements.
Identify optional process variations to maximize revenue opportunities.
Utilize KPI dashboards to track efficiency, compliance, and signal detection.
Lead global harmonization of PV processes across regions and partners.
Ensure inspection readiness and quality excellence for regulatory audits.
Collaborate with RA, QA, Medical Affairs, and Clinical Development to integrate safety insights to product lifecycle decisions.
C. Process Improvement & Innovation
Lead process mapping, digital transformation, and automation initiatives.
Implement advanced PV technologies, including AI-driven case processing.
Improve scalability, efficiency, and data quality across teams.
Drive successful change management initiatives for system/process upgrades.
Benchmark industry trends to stay competitive and innovative.
Ensure governance aligned with organizational change initiatives.
D. Cross-Functional Collaboration
Serve as strategic interface between PV Ops and key business functions.
Integrate safety intelligence into corporate strategy, portfolio management, and market expansion.
Align global affiliates and regional offices on harmonized safety practices.
Contribute to governance committees and safety boards.
Promote shared accountability and a culture prioritizing patient safety.
4. Qualifications
Education
Advanced degree preferred.
Experience
15+ years of pharmacovigilance experience.
At least 10 years in senior operational leadership with P&L responsibility.
Experience in global PV environments within CROs or PV service providers.
Technical Knowledge
Deep understanding of global PV regulations, GVP modules, and drug safety.
Familiarity with safety databases (Argus, ArisG) and PV technologies.
Skills
Strategic leadership and decision-making
Operational excellence and process optimization
Regulatory compliance and risk management
Cross-functional collaboration
Strong communication, negotiation, and interpersonal skills
High attention to detail with strong analytical ability
5. Additional Information
Work Culture & Values
PrimeVigilance emphasizes diversity, inclusion, and equal opportunities.
Core company values:
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
What the Company Offers
Internal training and career development
Strong focus on personal and professional growth
Supportive, friendly work environment
Global collaboration with English as the primary working language
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