Spécialiste Principal (e), Pharmacovigilance / Senior Specialist, Pharmacovigilance
Mericalherbs
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, management and negotiation of local pharmacovigilance agreements, and local due diligence 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 activities
local pharmacovigilance agreements
local initiatives review
Nice-to-have
strategic thinking
project management skills
people development
drive change
inclusive environment
Key Requirements
Bachelor degree in Health, life science, nursing, medical science degree or equivalent
PharmD or MD preferred
At least 5 years experience in the pharmaceutical industry