Spécialiste Principal (e), Pharmacovigilance / Senior Specialist, Pharmacovigilance
Muckelab
Kirkland, ,
Hybrid
Adverse event management
Pharmacovigilance regulatory compliance
Local health authority liaison
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 serves as the point of contact for local health authorities and supports audits, inspections, and corrective action plans to ensure compliance with pharmacovigilance regulations.
The position embraces a hybrid workplace strategy combining remote work and in-person presence at the Kirkland head office, fostering an inclusive and diverse work environment.
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
Pharmacovigilance regulatory compliance
Local health authority liaison
Pharmacovigilance audits and inspections
Risk minimization implementation
Pharmacovigilance process improvement
Nice-to-have
Strong leadership and communication
Strategic thinking and project management
Negotiation and influencing skills
Fluency in French
Hybrid work environment
Cross-functional collaboration
Key Requirements
Bachelor degree in health or life sciences
Minimum 5 years pharmaceutical industry experience
Fluency in French
Experience with pharmacovigilance audits and inspections