Manager, Pharmacovigilance & Medical Information

Life Sciences

Toronto, ON

  • 2022-01-04
  • Our client is a leading pharmaceutical company that specializes in dermatological treatments with a mission to advance dermatology through innovation and manufacturing. They are looking for a Manager, Pharmacovigilance & Medical Information in the GTA.

    The successful candidate would be a member of the Pharmacovigilance department, and report to the Pharmacovigilance Regional Head.

    General Responsibilities:

    • Implements and maintains the Pharmacovigilance & Medical Information system, and ensures its effectiveness and compliance with internal guidelines and applicable Pharmacovigilance regulations for medicinal products, medical devices, biologics and cosmetics
    • Organizes and ensures appropriate management of medical enquiries from internal and external customers
    • Acts as the Local Safety Officer for Canada
    • Responsible for a Pharmacovigilance & Medical Information Associate
    • Manages a team and serves as a subject matter expert in medicinal products, medical devices, biologics, cosmetics Pharmacovigilance activities
    • Organizes regulatory intelligence activities
    • Contributes to the conduct and oversight of post marketing studies, including non-interventional studies and market research
    • Responsible for maintenance of the Quality System for Pharmacovigilance & Medical Information and local compliance
    • Ensures Pharmacovigilance department readiness for inspections and local audits
    • Develops CAPA plans and drives local implementation
    • Provides training to new employees and license partners / vendors (including local Market Research agencies) about adverse event collection and Reporting; organizes regular refresher training to employees.
    • Maintains a working knowledge of company policies and procedures, departmental processes and associated work instructions, evolving local and international regulations, guidelines and applicable directives, company products, and skin anatomy and skin common diseases

    Requirements:

    • 5+ years of relevant work experience in a pharmaceutical company or clinical trials
    • Working knowledge of FDA and Health Canada guidelines for post-marketing drugs, cosmetics, and medical device safety surveillance.
    • Working knowledge of medical terminology, medical conditions, chemical structures/biological systems, and drug products.
    • Familiar with relevant computer software such as Oracle Argus or similar Drug Safety database.
    • Ability to manage a team.
    • Bilingual in English/French is a strong asset.

    To apply, please submit your resume using the Apply Now button.

    We thank all interested applicants, however, only the candidates chosen for an interview will be contacted.