Local Pharmacovigilance Responsible (Deputy LPV)

(6 to 12-month contract)

Laval, Quebec (Hybrid)

Introduction The Local Pharmacovigilance Responsible (Deputy LPV) supports the oversight and execution of local pharmacovigilance activities to ensure compliance with global pharmacovigilance standards and local regulatory requirements. The role is responsible for the collection, assessment, reporting, and management of safety information, while helping to maintain an effective local pharmacovigilance system and promoting patient safety.

As the designated deputy to the LPV, this position supports pharmacovigilance compliance, risk management activities, regulatory reporting obligations, quality system oversight, and inspection readiness across the organization.

Responsibilities

- Support the implementation and maintenance of the local pharmacovigilance system in accordance with global and local regulatory requirements.
- Manage and process adverse event reports and other pharmacovigilance cases from all sources in compliance with internal procedures and reporting timelines.
- Conduct local literature reviews and ensure appropriate processing of safety information identified through literature monitoring.
- Support local signal detection activities and communicate potential safety signals to Global Safety.
- Maintain oversight of safety reporting activities related to clinical studies, non-interventional studies, and patient support or compassionate use programs.
- Provide local safety information for periodic safety reports and ensure local regulatory submissions are completed as required.
- Support the implementation and monitoring of Risk Management Plans (RMPs) and additional Risk Minimization Measures (RMMs).
- Coordinate responses to safety-related inquiries from regulatory authorities and support safety communications to healthcare professionals and consumers.
- Contribute to local labeling updates and implementation of safety-related regulatory commitments.
- Maintain the local pharmacovigilance quality system, including training, compliance monitoring,



documentation, and record management.
- Participate in the establishment, maintenance, and oversight of pharmacovigilance agreements with third-party partners and service providers.
- Support business continuity planning to ensure uninterrupted pharmacovigilance operations.
- Monitor changes in local pharmacovigilance regulations and assess their impact on local processes.
- Act as a key contact during pharmacovigilance audits and inspections and support the implementation of corrective and preventive actions (CAPAs).
- Promote a culture of patient safety, regulatory compliance, and pharmacovigilance awareness across the organization.

Requirements

- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related scientific discipline.
- Minimum 5 years of pharmacovigilance experience within the pharmaceutical, biotechnology, or CRO industry.
- Demonstrated hands-on experience managing pharmacovigilance case processing and safety reporting activities.
- Strong knowledge of Canadian pharmacovigilance regulations, Health Canada requirements, and Good Pharmacovigilance Practices (GVP).
- Experience supporting pharmacovigilance compliance activities, including CAPA management and quality system processes.
- Bilingualism (English and French) required.
- Experience collaborating with cross-functional stakeholders in a regulated pharmaceutical setting.
- Strong organizational, analytical, and problem-solving skills.
- Ability to manage multiple priorities while maintaining compliance with regulatory timelines.

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About Us

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📌 Local Pharmacovigilance Responsible (Laval)
🏢 Brunel
📍 Laval