Case Specialist – Clinical Trial Pharmacovigilance

About the role

We are seeking a Case Specialist to join our pharmacovigilance hub, focusing on clinical trial case management. The role involves ensuring the quality and regulatory compliance of vigilance cases while supporting medical evaluation and data entry activities.

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 cases, assess causal relationships, determine seriousness, and identify submission requirements.
• Validate documents produced by data managers, close vigilance files, and set up ICSR/MLM filters.
• Analyse inclusion/exclusion criteria for EV/MHRA cases and provide medical information support to the division.

Required profile

• Doctor or pharmacist qualification.
• At least 4 years experience in case quality control for service providers.
• Minimum 3 years experience processing clinical‑trial cases.
• Familiarity with current pharmacovigilance regulations.
• Strong teamwork, rigor and ability to multitask.
• Fluent communication in English and French.

Required skills

• SafetyEasy database.
• Argus database.
• General database handling.
• Microsoft Office suite.