msd
Spécialiste principal (e), pharmacovigilance / Senior Specialist, Pharmacovigilance
At a Glance
- Location
- CAN - Quebec - Kirkland (16750 Transcanada), Canada
- Work Regime
- hybrid
- Employment
- Full time
- Experience
- 5+ years
- Posted
- 2026-03-23
Key Requirements
Required Skills
Domain Knowledge
- Education
- Medical
- Pharmaceutical
- Regulatory
Requirements
Adverse Event Report, Compliance Monitoring, Data Analysis, Decision Making, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Regulatory Compliance, Regulatory Reporting, Risk Management, Safety Procedures, Strategic Planning, Training and Development
PharmD or MD preferred
Experience in the pharmaceutical industry (at least 5 years)
Experience with pharmacovigilance audits and/or Pharmacovigilance Health Authority Inspections
Responsibilities
Le/la Spécialiste principal(e), pharmacovigilance est responsable de la gestion des événements indésirables, incluant les soumissions aux autorités de santé des rapports périodiques et des rapports individuels de cas de sécurité (ICSR), ainsi que du suivi de la conformité.
Il/elle est également responsable des activités de pharmacovigilance pouvant inclure, sans s’y limiter : la réception et le suivi des cas de pharmacovigilance, la gestion et la négociation des ententes locales de pharmacovigilance, les activités locales de diligence raisonnable, la participation aux audits et inspections ainsi qu’aux activités de préparation connexes, la revue des initiatives locales afin d’assurer leur conformité aux exigences de pharmacovigilance, la gestion des procédures opérationnelles normalisées (SOP), la formation locale, la communication des enjeux de sécurité, le développement des talents, les projets spéciaux assignés, et l’exécution autonome des activités déléguées.
The Senior Specialist, Pharmacovigilance is responsible for adverse event management including aggregate and Individual Case Safety Report (ICSR) health authority submissions and compliance monitoring.
Responsible for execution of local pharmacovigilance processes and activities in collaboration with internal functional areas and external parties as assigned.
Serves as SME and supports local pharmacovigilance audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations.
Participates in and supports audits of contractual partners/vendors as necessary.