Specialist Pharmacovigilance ICSR Unit

About the role

We are looking for a Specialist Pharmacovigilance professional to manage individual case safety reports (ICSRs) and related safety information. The role is fully remote and contract‑based, offering the chance to work across case intake, data entry, quality review, follow‑up and compliance monitoring.

Key responsibilities

• Receive, triage and assess potential pharmacovigilance safety reports from multiple sources.
• Conduct duplicate searches and accurately enter cases into the safety database.
• Perform case quality checks, resolve data‑quality issues and transmit cases within required timelines.
• Follow‑up with reporters to obtain additional information and respond to clarification requests.
• Support periodic safety‑data reconciliations, investigate discrepancies and monitor regulatory submission timelines.
• Contribute to audits, inspections and inspection‑readiness activities.
• Participate in developing procedures, training materials and quality documents.
• Identify and implement process‑improvement opportunities and act as a subject‑matter expert when assigned.

Required profile

• Minimum two years of experience in an industry pharmacovigilance role.
• Practical experience processing individual case safety reports.
• Knowledge of pharmacovigilance regulations, case‑management processes and compliance requirements.
• Degree or equivalent qualification in health, life, medical science, pharmacy, nursing or related field.
• Strong written and verbal communication skills in English and French.

Required skills

• Experience using safety databases.
• Experience with case‑management systems.

What we offer

• A collaborative and supportive remote working environment.
• Exposure to a broad range of pharmacovigilance processes and projects.
• Opportunities for technical, regulatory and stakeholder‑management skill development.