Spécialiste Principal (e), Pharmacovigilance / Senior Specialist, Pharmacovigilance
Nerdgigs
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.
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 participation in audits and inspections.
This role 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 processes
local pharmacovigilance agreements
Nice-to-have
strategic thinking
people development
cross-functional collaboration
driving process improvements
Key Requirements
Minimum of 5 years experience in the pharmaceutical industry
Bachelor degree in Health, life science, nursing, medical science degree or equivalent