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Pharmacovigilance Governance Officer – France

2-5 years
Not Disclosed
10 Feb. 10, 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

Pharmacovigilance Governance Officer – France (Full-Time, Permanent)

Excelya | Full-Time | Permanent | France

Excelya, a leading European Contract Research Organization (CRO), is looking for a Pharmacovigilance Governance Officer to support safety reporting, quality system compliance, vendor oversight, and regulatory submissions. This role is crucial in ensuring adherence to pharmacovigilance requirements and collaborating with cross-functional teams.

Key Responsibilities

  • Support local product handling and Periodic Benefit-Risk Evaluation Report (PBER) submissions.
  • Ensure compliance with Quality Systems: Manage deviations and document updates using QualiPSO (Sanofi tool).
  • Oversee vendor management via the AEGIS tool.
  • Manage case processing and health authority (HA) submissions.
  • Coordinate additional risk minimization measures (aRMM):
    • Attend and contribute to Cross-Functional Team (CFT) meetings.
    • Follow up with Medical & Commercial teams.
    • Draft aRMMs in alignment with local labeling requirements.
  • Administer PSPV training:
    • Send training notifications.
    • Conduct training sessions for personnel.
    • Follow up on phone inquiries.
  • Report directly to the Country Safety Head.

Minimum Requirements

  • Master’s degree or Pharmacist’s diploma with a specialization in Pharmacovigilance.
  • 2 to 5 years of experience in pharmacovigilance roles within the pharmaceutical industry or CRO.
  • Strong command of English (both written and spoken).

This position is ideal for a detail-oriented professional passionate about drug safety, regulatory compliance, and quality systems.