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Patient Safety & Pharmacovigilance Officer – France

0-2 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

Patient Safety & Pharmacovigilance Officer – France (Full-Time, Permanent)

Excelya | Full-Time | Permanent | France

Excelya, a leading Contract Research Organization (CRO) in Europe, is looking for a Patient Safety & Pharmacovigilance (PSPV) Officer to support PV transfer projects, safety data exchange agreements (SDEA), and PASS studies. This role involves managing compliance tracking, coordinating due diligence processes, and supporting safety operations across various platforms.

Key Responsibilities

PSPV Alliance Management

  • Maintain and update the PV Transfer Projects data tracker in Smartsheet.
  • Assist in coordinating PV Transfer Projects during Due Diligence, Active Inbound, and Active Outbound phases.
  • Perform system administration review and cleanup of PV Transfer Projects in Smartsheet.
  • Support training, orientation, and communication workstreams by preparing materials and updating intranet sites.
  • Prepare PV Transfer Project reports and slide decks for QPPV meetings.
  • Collect SDEA data during Due Diligence for Outbound PV Transfer Projects.

Post-Authorization Safety Studies (PASS)

  • Manage and track PASS activities, ensuring epidemiologists update PASS trackers.
  • Maintain and update the PASS pgMO SharePoint site.
  • Create study-level documents and templates in Smartsheet, Teams, and SharePoint.
  • Assist with standardized communications and follow-ups.
  • Support Trial Master File (TMF) transfers for Sequoia (Veeva Vault CMS) migration and quality control.

Minimum Requirements

  • Pharmacist or Master’s degree in a relevant field.
  • Specialized expertise in product life cycle management.
  • Strong IT skills, with experience using Smartsheet, Veeva Vault CMS, SharePoint, and Teams.

This role is ideal for a detail-oriented professional with a passion for pharmacovigilance, compliance, and patient safety.