Spécialiste Principal (e), Pharmacovigilance / Senior Specialist, Pharmacovigilance
39med
Kirkland, Canada
Hybrid
Adverse event reporting
Pharmacovigilance regulations
Compliance monitoring
The Senior Specialist, Pharmacovigilance is responsible for adverse event management including aggregate and Individual Case Safety Report (ICSR) health authority submissions and compliance monitoring
Job Summary
The Senior Specialist, Pharmacovigilance is responsible for adverse event management including aggregate and Individual Case Safety Report (ICSR) health authority submissions and compliance monitoring.
This role involves serving as the point of contact for the local Health Authority for pharmacovigilance related questions and supporting local pharmacovigilance audits and inspections.
The position requires fluency in French and offers a hybrid work arrangement combining remote and in-person work.
Matching Summary
The Senior Specialist, Pharmacovigilance is responsible for adverse event management including aggregate and Individual Case Safety Report (ICSR) health authority submissions and compliance monitoring.
Skills & Requirements
Must-have
Adverse Event reporting
Pharmacovigilance regulations
Compliance monitoring
Health authority submissions
Risk management
Nice-to-have
Strategic thinking
People development
Cross-functional collaboration
Process improvement
Key Requirements
Minimum 5 years pharmaceutical industry experience
Bachelor degree in Health, life science, nursing, medical science or equivalent