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Laval

    Director, Field and Executive - Laval, QC, Canada - Bausch Health Companies

    Bausch Health Companies
    Bausch Health Companies Laval, QC, Canada

    1 week ago

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    Description

    Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.

    Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.

    At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.

    Act as a local PV contact person for local Health Authority
    Act as a local PV contact person for audits and inspections and inform GPRM of incoming inspections/external audits

    Establish, implement, and manage the MAH PV system, in accordance with relevant corporate procedures, Safety Data Exchange Agreements (SDEAs) and local regulations.

    Ensure creation, maintenance and updates of local pharmacovigilance SOPs/WIs in according with local regulations and in line with Global SOPs
    Oversight of local vendor/partner (s) conducting local PV activities
    Provide coordination and support for internal Pharmacovigilance activities
    Ensure collection of drug safety information in the territory
    Can participate in translation, reconciliation and follow-up if needed
    o Acquiring data necessary for Aggregate reports preparation
    authorizations/licenses in Canada
    Implement, in conjunction with SDEA Team, local safety agreements with partners
    Support review of local SDEAs and compliance (especially with local PV contractors) in cooperation with the global SDEA team
    Monitor submission of Aggregate reports in collaboration with Regulatory Affairs
    Liaise with Global and local functions for pharmacovigilance activities, as defined
    Responsible for informing (in collaboration with GPRM team) Canadian Medical and Regulatory team about any safety issues in Canada
    Ensure local literature review and monitoring of the CanadaVigilance website is in place
    Collaborate with Medical Affairs, Marketing, Regulatory Affairs and partners to refine the RMP and aRMMS strategies
    Communicate any urgent safety issues to upper GPRM management
    Ensure local process for complaints/adverse events collection and reporting to GPRM is in place
    Manage or assist in management of PV audits and inspections from external regulatory agencies, partners or corporate auditors.
    Establish local metrics and other monitoring systems to measure and verify local compliance
    Prepare and manage local Non-Conformances/Deviations and CAPA
    Participate in GPRM training activities and regular TCs
    Organize PV training for local employees and local contract vendors
    Perform Health Authority Website monitoring and inform GPRM of changes in local regulation pertaining to Pharmacovigilance
    Qualifications / Training
    University degree with Pharmaceutical/Medical/Scientific background

    Languages:
    excellent French and English skills
    Technical knowledge of job-related systems
    Knowledge of PV-related local regulations and understanding of International Pharmacovigilance regulations

    Computing skills:
    user requiring advanced Literacy (Microsoft Office applications, Adobe Acrobat, Safety database)
    A minimum of 8-10 years of relevant work experience in Pharmacovigilance
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