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Pharmacovigilance Governance Officer – France

2-5 years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 Description: Pharmacovigilance Specialist

Company Overview

Excelya, established in 2014, is a people-centered Contract Research Organization (CRO) dedicated to excellence in clinical research. With 800 Excelyates and a one-stop provider service model, Excelya is on the path to becoming Europe’s clinical research leader. The organization fosters scientific, managerial, and human advancement to improve patient care.

What We Offer

The selected candidate will support pharmacovigilance (PV) activities, ensuring compliance with local and international safety regulations. Responsibilities include:

Key Responsibilities

Pharmacovigilance & Safety Activities

  • Handle local products and Periodic Benefit-Risk Evaluation Reports (PBER) reporting.
  • Manage case processing, including Health Authority (HA) submissions.
  • Draft and distribute additional Risk Minimization Measures (aRMMs) in alignment with local labeling requirements.
  • Ensure proper aRMM distribution, including participation in Cross-Functional Team (CFT) meetings.
  • Follow up with Medical & Commercial teams regarding safety measures.

Quality System & Compliance

  • Manage deviations using the Sanofi QualiPS0 tool.
  • Update quality documents in compliance with industry standards.
  • Oversee vendor activities using the AEGIS tool.

Training & Reporting

  • Facilitate Pharmacovigilance (PSPV) training, including:
    • Sending out training notifications.
    • Conducting PV training sessions for personnel.
    • Following up on training-related inquiries and phone calls.
  • Report directly to the Country Safety Head.

Minimum Requirements

Education & Experience

  • Master’s degree or Pharmacist’s diploma in Pharmacovigilance.
  • 2 to 5 years of experience in pharmacovigilance and safety-related activities within the pharmaceutical industry or CRO.

Skills & Competencies

  • Strong understanding of safety regulations and compliance requirements.
  • Proficiency in English (both written and verbal).
  • Detail-oriented with excellent organizational and problem-solving skills.
  • Ability to work cross-functionally with medical, commercial, and regulatory teams.