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Sdea Safety Project Manager – France

2-5 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: M.Sc.M.Pharm 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

SDEA Safety Project Manager – France (Full-Time, Permanent Contract)

Excelya | Full-Time | Permanent | France

Excelya, a leading CRO founded in 2014, is dedicated to advancing clinical research with care. With a team of 800+ Excelyates, we are committed to becoming Europe’s top clinical research organization. Our one-stop provider model—encompassing full-service, functional service provider (FSP), and consulting solutions—enables professionals to thrive in diverse and impactful projects.

At Excelya, we foster an environment that encourages intellectual growth, professional development, and collaboration, ensuring that every team member can reach their full potential.

Position Overview

We are looking for an SDEA Safety Project Manager to support pharmacovigilance (PV) and safety activities within clinical research. Based in Gif-sur-Yvette, France, you will be responsible for monitoring case management processes, ensuring regulatory compliance, and overseeing safety data quality control.

Key Responsibilities

  • Respond to case management inquiries from platforms.
  • Monitor case processing timelines and investigate reporting/transmission delays.
  • Conduct weekly quality control for case processing, including:
    • Data entry verification.
    • Coding and narrative writing reviews.
    • Medical review of cases.
  • Edit and review case listings for accuracy and consistency with source documents.
  • Ensure corrections and clarifications in SharePoint are properly addressed by platforms.
  • Sign off on quality control for safety case management.
  • Participate in quality control of clinical study case narratives for clinical study reports.
  • Supervise pharmacovigilance case reconciliation with partners (SDEA) and the clinical database.

Required Skills & Qualifications

  • Master’s degree or PharmD in Pharmacovigilance.
  • 2 to 5 years of experience in pharmacovigilance/safety-related roles within the pharmaceutical industry or a CRO.
  • Strong understanding of case processing and regulatory compliance.
  • Fluent in English to manage global safety operations.
  • Mobility to Gif-sur-Yvette, France.

Join Excelya and become a key player in ensuring patient safety and regulatory compliance in clinical research!