Senior Pharmacovigilance Specialist
Job Summary
To support regulatory intelligence and submissions, the full-time Senior Pharmacovigilance Specialist will manage adverse event submissions, ensure compliance with global pharmacovigilance requirements, and contribute to process improvements in a fast-paced, global environment.
Key responsibilities
- Manage expedited and non-expedited Individual Case Safety Report (ICSR) submissions and ensure compliance with reporting requirements
- Generate Argus-based reports for periodic safety submissions and support regulatory intelligence activities
- Conduct Performance Qualification (PQ) testing for system upgrades and participate in process improvement projects
Required qualifications
- High school diploma required; post-secondary education in a life sciences discipline preferred
- Minimum of 3 years' experience with pharmacovigilance safety databases and regulatory compliance activities
- Experience with Oracle Argus Safety or similar safety databases is highly desirable
- Knowledge of xEVMPD and global pharmacovigilance regulations is an advantage
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