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Executive Vice President, Pharmacovigilance Operations (East Coast)

0-2 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 Operations (East Coast)

Location: Remote (US – East Coast preferred)
Employment Type: Full-Time
Department: PV Operations
Company: PrimeVigilance (Ergomed Group)


Company Overview

PrimeVigilance, part of the Ergomed Group, is a global mid-size pharmacovigilance service provider established in 2008. We support pharma and biotech partners worldwide across:

  • Medical Information

  • Pharmacovigilance

  • Regulatory Affairs

  • Quality Assurance

We operate globally across Europe, North America, and Asia covering all therapy areas, including medical devices.
PrimeVigilance emphasizes:

  • Strong training & development

  • Employee well-being & work-life balance

  • A collaborative, inclusive culture


Role Summary

The Executive Vice President, Pharmacovigilance Operations oversees all global PV operational activities, ensuring regulatory compliance, operational excellence, and alignment with corporate strategy.
The role includes:

  • Leading PV teams globally

  • Driving process optimization & innovation

  • Managing KPIs, performance, and operational quality

  • Ensuring PV systems meet global regulatory standards

  • Supporting business growth through strategic and operational leadership


Key Responsibilities


1. Leadership & Strategy

  • Provide strategic direction for global PV operations aligned with business goals and regulations.

  • Develop and implement long-term operational strategies for service expansion and performance improvement.

  • Forecast resource needs and allocate effectively across global teams.

  • Mentor and lead PV teams, promoting a culture of accountability and high performance.

  • Represent PV Operations in executive meetings, governance boards, and leadership forums.

  • Define and monitor KPIs to track operational performance and quality.

  • Partner with Enterprise PMO/BPO to deliver Value Creation Plan (VCP) outcomes.


2. Operational Excellence

  • Champion a culture of excellence, innovation, and continuous improvement across PV operations.

  • Optimize and standardize global PV processes:

    • Case processing

    • Literature surveillance

    • Medical scientific affairs

    • PV regulatory & medical information

    • PV project management

  • Streamline workflows, leverage automation, and integrate new technologies.

  • Identify optional service variations to maximize revenue opportunities.

  • Maintain performance dashboards and monitor operational metrics.

  • Lead global harmonization of PV processes across affiliates and partners.

  • Ensure inspection readiness and compliance with regulatory expectations.

  • Collaborate cross-functionally (Regulatory, QA, Clinical Development, Medical Affairs) to integrate safety insights into product lifecycle strategies.


3. Process Improvement & Innovation

  • Drive transformation through process mapping, automation, and AI-supported tools.

  • Implement advanced PV technology solutions (AI case processing, analytics tools, efficiency systems).

  • Lead global change management initiatives aligned with evolving regulations and corporate goals.

  • Eliminate redundancies to improve data quality and reduce cycle times.

  • Adopt industry best practices and benchmarking for competitive advantage.

  • Ensure governance compliance for new change initiatives with Enterprise PMO/BPO.


4. Cross-Functional Collaboration

  • Act as a strategic link between PV Operations and internal stakeholders.

  • Embed safety intelligence into product lifecycle and business planning decisions.

  • Harmonize global safety processes between affiliates, regions, and headquarters.

  • Provide expert PV input to governance committees and safety boards.

  • Promote shared accountability for patient safety across departments.


Qualifications

Education

  • Advanced degree preferred (Life Sciences, Pharmacy, Medicine, etc.)

Experience

  • 15+ years of pharmacovigilance experience

  • 10+ years in PV operational leadership with P&L responsibility

  • Strong experience in global PV operations within a CRO or PV service provider

  • Expertise in global PV regulations, GVP modules, and drug safety principles

  • Familiarity with safety databases (Argus, ArisG) and PV software tools

Skills

  • Strategic leadership & decision-making

  • Operational excellence & process optimization

  • Regulatory compliance & risk management

  • Strong communication, negotiation & interpersonal abilities

  • High attention to detail, analytical mindset

  • Strong project and resource management skills


Why Join PrimeVigilance?

  • Global training and career development

  • Strong focus on personal and professional growth

  • Friendly, collaborative, and supportive culture

  • Work with global colleagues using English as the company language

  • Core company values:

    • Quality

    • Integrity & Trust

    • Drive & Passion

    • Agility & Responsiveness

    • Belonging

    • Collaborative Partnerships