Spécialiste Principal (e), Pharmacovigilance / Senior Specialist, Pharmacovigilance
29
Kirkland, Quebec, Canada
Hybrid
Adverse event management
Health authority submissions
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 ensuring compliance with local laws and regulations.
The position requires strong leadership, communication, decision making, and problem-solving skills with in-depth knowledge of PV regulations and processes.
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 management
Health authority submissions
Compliance monitoring
Pharmacovigilance regulations
Local literature screening
Nice-to-have
Strategic thinking
Cross-functional collaboration
Driving process improvements
Talent development
Key Requirements
Minimum 5 years pharmaceutical industry experience
Bachelor degree in Health, life science, nursing, medical science or equivalent