Pharmacovigilance Manager
4 weeks ago
We are seeking a highly skilled Pharmacovigilance Manager to lead and oversee all aspects of pharmacovigilance activities, ensuring compliance with Health Canada regulations and global pharmacovigilance standards. The ideal candidate will have expertise in drug safety, regulatory reporting, and risk management, and will play a key role in maintaining compliance while supporting new product launches.
Key Responsibilities:
- Manage all pharmacovigilance activities, including adverse event detection, assessment, processing, and reporting to regulatory authorities.
- Ensure quality, validity, accuracy, and timely submission of safety reports.
- Conduct quality control (QC) checks on adverse events, product complaints, and related documentation.
- Prepare and submit pharmacovigilance reconciliation reports in alignment with regulatory requirements.
- Provide training programs for internal teams to ensure compliance with Good Pharmacovigilance Practices (GVP).
- Lead risk management plan (RMP) development to meet Health Canada’s Marketed Health Products Directorate (MHPD) requirements.
- Drive audit readiness and compliance, including audit preparation and training for program teams.
- Monitor pharmacovigilance key performance indicators (KPIs) and implement process improvements.
- Lead pharmacovigilance activities for new product launches and ensure alignment with regulatory expectations.
- Maintain pharmacovigilance agreements with external vendors and conduct required reconciliations.
Qualifications & Experience:
- Qualified Healthcare Professional (e.g., Pharmacist, Nurse, Physician) with relevant expertise in drug safety.
- 5-10 years of experience in Pharmacovigilance, Drug Safety, Medical Affairs, Regulatory Affairs, or related fields.
- Strong understanding of Health Canada’s GVP regulations, Good Documentation Practices (GDP), and ICH guidelines.
- Experience handling GVP audits, CAPA generation, and compliance reporting.
- Knowledge of risk-benefit assessment, toxicology, pharmacology, and disease state management.
- Strong leadership, communication, and team management skills.
- Ability to work in a fast-paced, compliance-driven environment with multiple priorities.
- Bilingualism (English/French) is an asset.
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