Executive Vice President – Pharmacovigilance Operations
Employment Type: Full-time
Work Mode: Remote
Department: PV Operations
Company: PrimeVigilance (Ergomed Group)
1. Company Overview
PrimeVigilance, part of the Ergomed Group, is a specialised global provider of:
Medical Information
Pharmacovigilance
Regulatory Affairs
Quality Assurance
Founded in 2008, the company has grown organically with teams across Europe, North America, and Asia. It supports pharmaceutical and biotechnology clients of all sizes and across all therapeutic areas, including medical devices. The company emphasizes employee development, well-being, mental health, and work–life balance.
2. Role Summary
The Executive VP, Pharmacovigilance Operations is responsible for the leadership, strategic direction, and operational excellence of global PV activities.
This role ensures:
Regulatory compliance
High-quality safety operations
Efficient resource utilization
Process optimization using metrics and technology
It provides executive-level leadership to PV teams while driving cost, speed, and quality improvements across all global PV functions.
3. Key Responsibilities
A. Leadership & Strategy
Provide strategic direction for global PV operations aligned with corporate goals.
Develop and implement long-term operational strategies supporting business growth.
Lead expansion of Safety & PV services focusing on revenue, margins, and resources.
Mentor and develop PV teams, ensuring high performance and accountability.
Partner with Enterprise PMO/BPO to deliver Value Creation Plan (VCP) objectives.
Represent PV operations in executive meetings, governance boards, and leadership forums.
Forecast resource needs, plan for upcoming projects, and ensure optimal resource allocation.
Define KPIs and monitor operational and team performance.
B. Operational Excellence
Promote a culture of excellence, innovation, and continuous improvement.
Standardize and enhance end-to-end PV processes:
PV project management
Case processing & literature
Medical scientific affairs
PV regulatory
Medical information
Streamline workflows using automation and modern technologies.
Identify optional process variations and collaborate with commercial leadership to optimize revenue.
Monitor KPIs and dashboards to track compliance, efficiency, and signal detection.
Drive global harmonization of PV activities across affiliates and regions.
Lead inspection readiness and ensure PV systems exceed regulatory expectations.
Collaborate with RA, QA, Medical Affairs, and Clinical Development for lifecycle safety integration.
C. Process Improvement & Innovation
Lead operational excellence initiatives through process mapping and automation.
Evaluate and adopt advanced PV tools such as AI-assisted case processing.
Implement process efficiencies improving accuracy, scalability, and cycle time.
Drive change management initiatives to support evolving regulatory and business needs.
Benchmark industry best practices to maintain a competitive advantage.
Ensure governance adherence during initiation and execution of change initiatives.
Work with Enterprise PMO/BPO to transform PV processes through technology and analytics.
D. Cross-Functional Collaboration
Act as a strategic link between PV Operations and internal stakeholders.
Embed safety insights into corporate business planning and product lifecycle strategies.
Harmonize safety procedures and communication across regions and headquarters.
Participate in governance committees and safety boards with expert PV input.
Promote shared ownership of patient safety across departments.
4. Qualifications
Education
Advanced degree preferred.
Professional Experience
15+ years of pharmacovigilance experience.
Minimum 10 years in an operational leadership role with P&L responsibility.
Proven global PV operations experience in a CRO or PV service provider environment.
Technical Expertise
Strong knowledge of global PV regulations, GVP modules, and safety principles.
Experience with safety databases (Argus, ArisG) and PV technology platforms.
Skills
Strategic leadership and decision-making
Operational excellence & process optimization
Regulatory compliance & risk management
Cross-functional collaboration & communication
Strong negotiation, interpersonal, and analytical skills
High attention to detail
5. Additional Information
What the Company Offers
Comprehensive training and internal career development
Strong focus on personal and professional growth
Supportive and collaborative global work culture
Opportunity to work with international teams (English as primary language)
Core Values
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |LA :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Yavne | Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |Remote :
Bishop | Melbourne | Switzerland | Nairobi | Slovakia | Lenexa | Xzagreb | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Green Way | Remote, USA | Texas | Ireland | Springville | Hammond | Remote - South America (Latin Americal) | Zaragoza | Minnesota | Remote | Medan | French | Tulsa | Hungary | Faridabad | Remote - Middle East | Victoria | Lousiana | Thailand | Remote - Africa | Manipal | Castlebar | Riga | Leinster | Belgium | Bountiful | McFarland |Republic of Colombia :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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