Global Pharmacovigilance Case Processing Specialist

Excelya

Boulogne-Billancourt

On-site

EUR 52,000 - 75,000

Full time

7 days ago
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Job summary

Excelya in France is seeking a Pharmacovigilance Case Processing Officer to join our global safety team and ensure timely, compliant case processing across studies.

You will act as main contact for case processing vendors, monitor timelines, perform quality checks (data entry, MedDRA coding, narratives), and support reconciliation activities under SDEA/PVA, contributing to continuous quality improvements in a fast-paced international environment.

Qualifications

  • Bachelor’s degree or higher in Pharmacy or Life Sciences or related field.
  • Solid experience in Pharmacovigilance with strong case processing expertise.
  • Hands-on experience with Argus Safety or equivalent safety databases.
  • Strong knowledge of global pharmacovigilance regulations and guidelines.

Responsibilities

  • Act as a point of contact for case processing vendors and respond to operational queries.
  • Monitor case processing timelines and identify root causes of delays.
  • Perform quality reviews: data entry verification, MedDRA coding, narrative review, and QC checks.
  • Manage corrections, clarifications, and follow-up requests with external partners.
  • Review and approve quality control activities for assigned products and studies.
  • Support case reconciliation activities with business partners under SDEA/PVA.
  • Contribute to deviation management: RCA, CAPA, and continuous quality improvements.
  • Collaborate with Pharmacovigilance Quality, Global Safety Operations, and cross-functional stakeholders.

Skills

Pharmacovigilance
Case processing
Vendor management
MedDRA coding
Quality control
Global regulations
MS Office

Education

Bachelor's degree or higher in Pharmacy/Life Sciences

Tools

Argus Safety

Job description

Excelya in France is seeking a Pharmacovigilance Case Processing Officer to join our global safety team and ensure timely, compliant case processing across studies.

You will act as main contact for case processing vendors, monitor timelines, perform quality checks (data entry, MedDRA coding, narratives), and support reconciliation activities under SDEA/PVA, contributing to continuous quality improvements in a fast-paced international environment.

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