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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 (Employees can work remotely)
Job Type: Full-time
Department: Business Development


About the Company:

PrimeVigilance, part of Ergomed PLC, is a global pharmacovigilance service provider with staff across Europe, North America, and Asia. Founded in 2008, PrimeVigilance supports pharmaceutical and biotechnology partners, ensuring first-class service in pharmacovigilance, medical information, regulatory affairs, and quality assurance across all therapy areas, including medical devices. PrimeVigilance values employee well-being, providing excellent training and a work-life balance that fosters high-quality service.


Job Responsibilities:

  • Pharmacovigilance Leadership:

    • Assume the role of European Union/United Kingdom Qualified Person Responsible for Pharmacovigilance (EU/UK QPPV) or act as the deputy

    • Provide expert advice on all areas of pharmacovigilance

    • Author and/or review pharmacovigilance procedural documents

    • Collaborate with internal teams to provide input into PV processes

    • Advise clients on pharmacovigilance regulatory requirements and strategies for drug safety

  • Client and Internal Support:

    • Participate in audits and inspections as required

    • Perform gap analysis of pharmacovigilance systems

    • Support departments in executing internal initiatives and technological improvements

    • Provide PV consultancy services in line with contractual agreements

    • Prepare and deliver complex client-facing PV reports, presentations, and regulatory documents

  • Training and Development:

    • Prepare and perform advanced PV training, both internally and for clients

    • Represent the company at international pharmacovigilance congresses and conferences

    • Support business development (BD) and marketing activities by creating collateral, writing articles, and preparing webinars

  • Regulatory Support:

    • Keep abreast of pharmacovigilance legislation and support company decisions regarding PV regulatory requirements

  • Leadership and Mentoring:

    • Provide leadership, guidance, and mentoring to junior pharmacovigilance staff or consultants


Required Qualifications:

  • Education:

    • University degree in a life sciences subject

  • Experience:

    • Solid experience in pharmacovigilance and previous experience as an EU or UK QPPV in charge of complex PV systems

    • Previous experience in pharmacovigilance inspections

    • Experience in business development activities related to PV services

    • Experience presenting at international PV events

  • Skills:

    • Strong communication, presentation, and leadership skills

    • Fluent in English; additional languages are desirable


Preferred Qualifications:

  • Experience:

    • Previous line management experience (desirable but not mandatory)


Additional Information:

  • PrimeVigilance is committed to diversity, equity, and inclusion, creating a workplace where people from all cultural backgrounds, genders, and ages can thrive.

  • The company offers training and career development opportunities, a supportive work environment, and the opportunity to work with colleagues globally.