Job Title: Executive Vice President, Pharmacovigilance (PV) Operations – East Coast
Department: PV Operations
Employment Type: Full-time (Remote)
Company Overview
PrimeVigilance (part of the Ergomed Group) is a specialised, mid-size pharmacovigilance service provider established in 2008. With staff based across Europe, North America, and Asia, we deliver expert services in:
Pharmacovigilance
Medical Information
Regulatory Affairs
Quality Assurance
We take pride in our consistent global growth and long-term partnerships with pharmaceutical and biotechnology companies of all sizes, covering all therapy areas including medical devices.
At PrimeVigilance, we invest heavily in training, development, and employee well-being, fostering a healthy work-life balance that supports high-quality service delivery and professional excellence.
Position Summary
The Executive Vice President (EVP), Pharmacovigilance Operations will lead and oversee all global PV operational activities, ensuring compliance with regulatory requirements, SOPs, and industry standards.
This strategic leadership role focuses on optimizing cost, quality, and delivery speed through data-driven management. The EVP will manage global teams, enhance operational frameworks, and collaborate cross-functionally to uphold patient safety and regulatory excellence.
Key Responsibilities
1. Leadership & Strategy
Provide strategic direction for PV operations in alignment with corporate goals and regulatory requirements.
Develop and implement operational strategies supporting company objectives and long-term business growth.
Lead and mentor PV operational teams, fostering accountability, high performance, and continuous learning.
Drive expansion of Safety and PV services in terms of revenue, operational margins, and resources.
Partner with the Enterprise PMO/BPO to achieve the Value Creation Plan (VCP) objectives.
Represent PV operations in senior management meetings, governance boards, and leadership forums.
Forecast resource needs and ensure efficient allocation across global projects.
Define and monitor KPIs to measure team and process performance.
2. Operational Excellence
Embed a culture of excellence, innovation, and continuous improvement across global PV operations.
Standardize and optimize PV processes (case processing, literature review, medical information, regulatory activities).
Streamline workflows, integrate automation, and adopt emerging technologies for greater efficiency and accuracy.
Collaborate with commercial leadership to identify and monetize optional service variations.
Use performance dashboards and metrics to monitor compliance, efficiency, and signal detection.
Drive harmonization of PV processes across global regions and affiliates.
Ensure inspection readiness and compliance with all regulatory expectations.
Strengthen collaboration with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development.
3. Process Improvement & Innovation
Lead PV transformation through automation, AI-driven solutions, and advanced analytics.
Conduct process mapping to identify redundancies and optimize resource utilization.
Benchmark industry best practices to enhance competitive advantage.
Oversee adoption of new systems and technologies through effective change management.
Ensure governance and oversight of all new and ongoing improvement initiatives in collaboration with the Enterprise PMO/BPO.
4. Cross-Functional Collaboration
Serve as a strategic liaison between PV Operations and other business units.
Integrate safety insights into business and product lifecycle decisions.
Promote alignment between global affiliates, regional offices, and headquarters.
Contribute to governance committees and safety boards with expert PV input.
Foster shared accountability and patient safety culture across departments.
Qualifications
Education & Experience
Advanced degree (PharmD, MD, PhD, or equivalent preferred).
Minimum 15 years of pharmacovigilance experience, including 10+ years in operational leadership with P&L responsibility.
Proven success managing global PV operations within a CRO or PV service provider environment.
Technical & Professional Skills
Strong knowledge of global PV regulations, GVP modules, and drug safety principles.
Proficiency with safety databases (e.g., Argus, ArisG) and PV software tools.
Expertise in strategic leadership, operational excellence, and regulatory compliance.
Strong project management and analytical abilities.
Excellent communication, negotiation, and interpersonal skills.
Core Competencies
Strategic Leadership & Decision-Making
Process Optimization & Innovation
Regulatory Compliance & Risk Management
Cross-Functional Collaboration
Analytical Thinking & Attention to Detail
What We Offer
Competitive compensation package.
Ongoing training and professional development opportunities.
A friendly, supportive, and global work environment with English as the company language.
Emphasis on personal growth, inclusivity, and mental well-being.
Opportunities to collaborate across international teams.
Our Core Values
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Join Us
Be part of a company that values excellence, diversity, and patient safety. Join PrimeVigilance and help make a positive impact on patients’ lives worldwide.
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