Senior Pharmacovigilance Specialist

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