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Sdea Safety Project Manager – France

Excelya
Excelya
2-5 years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time 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 Case Manager

Location: Gif sur Yvette, France (Full-time)
Company: Excelya (Contract Research Organization)

Company Overview

Excelya is a people-centered CRO founded in 2014, dedicated to providing a personal, authentic experience in the healthcare industry. With over 800 professionals across Europe, Excelya is on a path to becoming the clinical research leader. The company focuses on collaboration, leveraging a unique one-stop provider service model that allows team members to evolve through diverse projects.

What We Offer

Excelya offers a stimulating professional environment, where team members contribute to the development of life-changing therapies while expressing their full potential.

Main Responsibilities

Case Management & Monitoring

  • Respond to emails from platforms regarding case management.
  • Monitor case processing times, identifying reasons for delays in reporting or transmitting cases.
  • Participate in weekly quality control of case processing (data entry, coding, narrative writing) on platforms, including medical review of cases.
  • Edit listings, check data consistency against source documents, and ensure overall data integrity.
  • Provide listings with corrections or requests for clarification in SharePoint on platforms.
  • Ensure response accuracy from platforms regarding corrections or requests for clarification.
  • Sign off on quality control for case management.

Clinical Study Case Narratives & Reconciliation

  • Participate in the quality control of clinical study case narratives for inclusion in the clinical study report.
  • Oversee the reconciliation of pharmacovigilance cases with partners (via SDEA) and cases with the clinical database outsourced to platforms.

Minimum Requirements

Education & Experience

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

Skills & Competencies

  • Strong proficiency in English.
  • Flexibility to be mobile in Gif sur Yvette, France.

Additional Information

  • This is a full-time position with Excelya, located in Gif sur Yvette, France.