Instagram
youtube
Facebook

Patient Safety & Pharmacovigilance Officer – France

0-2 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: PSPV Alliance Management & PASS Specialist

Company Overview

Excelya, established in 2014, is a people-centered Contract Research Organization (CRO) dedicated to advancing clinical research. With a team of 800 Excelyates, the company is committed to becoming Europe’s leading CRO through its full-service, functional service provider, and consulting models. Excelya collaborates with industry experts to drive scientific, managerial, and human advancements in healthcare.

What We Offer

The selected candidate will support Pharmacovigilance (PV) Alliance Management and Post-Authorization Safety Studies (PASS) activities, ensuring compliance with regulatory requirements.


Key Responsibilities

PSPV Alliance Management

  • Manage and update the PV Transfer Projects data tracker in Smartsheet.
  • Coordinate PV Transfer Projects across Due Diligence, Active Inbound, and Active Outbound phases.
  • Perform system administration review and clean up former and active PV Transfer Projects in Smartsheet.
  • Support PSPV Alliance Management Training & Orientation by preparing materials and updating intranet sites.
  • Prepare PV Transfer Project reports and slide decks for QPPV meetings.
  • Assist with Safety Data Exchange Agreement (SDEA) data collection during Due Diligence for Outbound PV Transfer Projects.

Post-Authorization Safety Studies (PASS)

  • Track and manage PASS updates, including reminders for epidemiologists to update the PASS tracker.
  • Act as Business Archive Coordinator (BAC) for PASS activities (training provided).
  • Update and maintain the PASS pgMO SharePoint site.
  • Create study-level documents and resources using Smartsheet, Teams, and SharePoint libraries (training provided).
  • Assist with standardized communications and follow-ups.
  • Support TMF transfers by coordinating with IN Hub Resource for Sequoia (Veeva Vault CMS) migration and Quality Control.

Minimum Requirements

Education & Experience

  • Pharmacist or Master’s degree in a relevant field.
  • Specialized expertise at every stage of the product life cycle.

Skills & Competencies

  • Strong understanding of pharmacovigilance processes and regulatory requirements.
  • Proficiency in IT tools, including Smartsheet, SharePoint, Teams, and Veeva Vault CMS.
  • Excellent organizational, communication, and project management skills.
  • Ability to work collaboratively across teams in a fast-paced environment.