Instagram
youtube
Facebook

Executive Director, Pharmacovigilance Strategy

3+ years
Not Disclosed
10 April 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Director, Pharmacovigilance Strategy
Location: Remote
Employment Type: Full-time
Department: Business Development


About the Company:

PrimeVigilance, a part of Ergomed PLC, is a specialized mid-size pharmacovigilance service provider founded in 2008. With a global footprint across Europe, North America, and Asia, PrimeVigilance offers expert services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. The company has grown organically to become a global leader in pharmacovigilance support for pharmaceutical and biotechnology companies of all sizes across all therapeutic areas including medical devices.

PrimeVigilance invests heavily in staff training and development, promotes well-being and mental health, and fosters a balanced work environment, which in turn drives high-quality service delivery for clients.


Job Responsibilities:

  • Serve as a senior PV expert and strategic advisor with comprehensive regulatory knowledge

  • Provide scientific and medical support across the product lifecycle

  • Act as EU/UK Qualified Person Responsible for Pharmacovigilance (QPPV) or Deputy QPPV

  • Author and review complex pharmacovigilance and regulatory documents

  • Offer expert guidance on pharmacovigilance systems, procedures, and processes

  • Lead or support gap analyses of PV systems and participate in audits and inspections

  • Collaborate with internal departments to optimize PV processes

  • Deliver internal and client-focused advanced PV training sessions

  • Represent the company at international PV congresses and conferences

  • Support Business Development and Marketing by creating educational and promotional content

  • Stay updated on PV legislation and support strategic implementation of regulatory changes

  • Contribute to internal technological improvements and company projects

  • Mentor and lead junior staff and consultants

  • Prepare and deliver high-level client-facing PV reports, presentations, and strategic documents


Required Qualifications:

  • University degree in a life sciences field

  • Extensive experience in pharmacovigilance, including serving as an EU or UK QPPV

  • Strong background in regulatory inspections and PV systems management

  • Proven experience in PV business development activities

  • Track record of presenting at international PV events

  • Previous line management experience (preferred but not essential)

  • Strong communication, presentation, and leadership abilities

  • Fluent in English; additional languages are an advantage


What We Offer:

  • Comprehensive internal training and professional development opportunities

  • Strong emphasis on personal growth and career advancement

  • Friendly and collaborative work culture

  • Opportunity to engage with a global team, using English as the corporate language

  • A values-driven organization centered on:

    • Quality

    • Integrity & Trust

    • Drive & Passion

    • Agility & Responsiveness

    • Belonging

    • Collaborative Partnerships