Case Specialist – Pharmacovigilance (Clinical Trial)

About the role

ProductLife Group is seeking a qualified Case Specialist to join its Pharmacovigilance Hub. The role focuses on quality control and medical evaluation of vigilance cases arising from clinical trials, ensuring accurate data entry and regulatory compliance.

Key responsibilities

• Perform quality control of vigilance cases and conduct medical evaluation of reports.
• Enter case data into ad‑hoc databases or client‑specified formats.
• Follow up on case requests via phone or email and pre‑analyse complex cases before data entry.
• Code events using applicable dictionaries and assess causal relationships, seriousness, and event classification.
• Identify submission requirements, validate supporting documents, and close vigilance files.
• Set up ICSR/MLM filters, analyse inclusion/exclusion criteria, and provide medical information support.

Required profile

• Doctor or pharmacist by training.
• Minimum 4 years experience in case quality control for service providers.
• At least 3 years processing clinical‑trial cases.
• Familiarity with current pharmacovigilance regulations.
• Process‑oriented, rigorous, and able to work collaboratively.
• Strong communication skills in English and French.

Required skills

• SafetyEasy database
• Argus database
• Microsoft Office suite

What we offer

• Dynamic, international team environment.
• Opportunities for professional development in drug safety.