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Executive Vice President, Pharmacovigilance Operations

10-15 years
Not Disclosed
10 Nov. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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