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Executive Vice President, Pv Operations (East Coast)

15+ years
Not Disclosed
10 Oct. 2, 2025
Job Description
Job Type: Full Time Remote 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

🧾 Job Title: Executive Vice President, PV Operations (East Coast)

🏢 Company: PrimeVigilance (Ergomed Group)
📍 Location: Remote (East Coast, USA)
🕒 Employment Type: Full-time
📂 Department: PV Operations


🌍 About PrimeVigilance

PrimeVigilance is a specialized mid-size pharmacovigilance service provider, established in 2008, with staff across Europe, North America, and Asia.

  • Services: Medical Information, Pharmacovigilance (PV), Regulatory Affairs, Quality Assurance

  • Focus: Long-term partnerships with pharmaceutical and biotechnology companies, covering all therapy areas including medical devices

  • Culture: Employee-centric, with strong focus on well-being, training, and career development


🧾 Job Description

The Executive VP, PV Operations is responsible for leading global PV operations, ensuring regulatory compliance, operational efficiency, and patient safety. This role will manage PV teams, optimize processes, and collaborate cross-functionally to enhance the delivery of PV services.


🔹 Key Responsibilities

1. Leadership & Strategy

  • Provide strategic direction for PV operations aligned with corporate goals and regulatory expectations

  • Develop operational strategies to meet long-term business objectives

  • Lead and mentor PV operational teams, fostering accountability, high performance, and continuous learning

  • Partner with Enterprise PMO/BPO to implement the Value Creation Plan (VCP)

  • Represent PV operations in senior management meetings, governance boards, and leadership forums

  • Forecast future needs and allocate resources efficiently

  • Define KPIs and monitor team performance

2. Operational Excellence

  • Promote a culture of excellence and continuous improvement across global PV operations

  • Collaborate to standardize PV processes, including case processing, literature review, medical affairs, PV regulatory, and PV medical information

  • Optimize workflows, integrate emerging technologies, and enhance data accuracy and reporting timeliness

  • Lead inspection readiness and quality initiatives

  • Drive global harmonization of PV processes across regions and partners

3. Process Improvement & Innovation

  • Implement process mapping, automation, and technology adoption

  • Evaluate and implement advanced PV tools and AI-supported case processing

  • Lead change management initiatives to adapt PV operations to evolving needs

  • Streamline workflows, eliminate redundancies, and optimize resource allocation

  • Benchmark processes to identify improvements that drive competitive advantage

4. Cross-Functional Collaboration

  • Serve as a strategic bridge between PV operations and internal stakeholders

  • Embed PV insights into strategic business planning

  • Facilitate global alignment of safety processes and communications

  • Contribute to governance committees and safety boards

  • Promote a culture of shared accountability for patient safety


🎓 Qualifications

  • Advanced degree preferred

  • 15+ years of pharmacovigilance experience, including 10+ years in operational leadership with P&L responsibility

  • In-depth knowledge of global PV regulations, GVP modules, and drug safety principles

  • Proven experience managing PV operations in a global CRO or PV service provider

  • Strong leadership, strategic thinking, and project management skills

  • Excellent communication, negotiation, and interpersonal skills

  • Experience with safety databases (e.g., Argus, ArisG) and PV software tools

  • Expertise in regulatory compliance, process improvement, and cross-functional collaboration

  • High attention to detail and analytical abilities


🌟 Why PrimeVigilance

  • Training and career development opportunities internally

  • Emphasis on personal and professional growth

  • Friendly, supportive, and globally distributed working environment

  • English as the company language for global collaboration

Core Values:

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships

PrimeVigilance fosters an inclusive, human-centric workplace where employees contribute, grow, and impact patient lives positively.