Spécialiste Principal (e), Pharmacovigilance / Senior Specialist, Pharmacovigilance
microsatsystems.biz
Kirkland, 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.
They are also responsible for pharmacovigilance activities which may include but are not limited to: pharmacovigilance intake (follow-up activities), management and negotiation of local pharmacovigilance agreements, local due diligence activities, participation in audits and inspections and related readiness activities.
In line with our Company’s Hybrid Workplace Strategy, this position will be performed through a combination of remote work and in-person (Kirkland Head Office) based on the nature of work to be done.
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 processes
local literature screening
Nice-to-have
strong leadership skills
strategic thinking skills
cross-functional collaboration
driving process improvements
Key Requirements
Minimum 5 years pharmaceutical industry experience
Bachelor degree in Health, life science, nursing, medical science