Pharmacovigilance Manager

Company Description:

Mint Pharmaceuticals is a Canadian-owned generic pharmaceutical company based in Mississauga, Ontario. Founded in 2007, the organization focuses on delivering high-quality, affordable generic medicines and healthcare solutions to the Canadian market. Through product differentiation, reliable supply, and strong customer service, Mint Pharmaceuticals supports healthcare providers and patients across Canada. The company is committed to helping communities live longer, healthier lives by making essential treatments more accessible.

Join Mint Pharmaceuticals and play a key role in protecting patient safety, strengthening regulatory compliance, and advancing operational excellence.

Role Description:

Mint Pharmaceuticals is seeking an experienced Pharmacovigilance Manager to lead pharmacovigilance operations, ensure regulatory compliance, and strengthen our patient safety and quality systems. The successful candidate will bring approximately 10 years of PV experience, demonstrated expertise in PV audits and CAPA management, and the leadership skills to drive continuous improvement across our marketed product portfolio. This full-time Pharmacovigilance Manager role is a hybrid position based in Mississauga, ON. The Pharmacovigilance Manager oversees the collection, assessment, and reporting of safety data for Mint’s pharmaceutical products, ensuring compliance with Canadian pharmacovigilance regulations. Day-to-day responsibilities include managing adverse event case processing, maintaining safety databases, preparing and reviewing regulatory safety reports, and implementing risk management plans. The role collaborates with regulatory affairs, quality, and commercial teams to support product safety strategies and respond to safety-related inquiries. The Pharmacovigilance Manager also develops and updates pharmacovigilance procedures, trains internal teams on safety reporting requirements, and participates in safety audits and inspections. Experience in PV database implementation will be an asset.

Leadership Profile:

A proactive, detail-oriented leader with strong analytical, organizational, and communication skills; sound regulatory judgment; and the ability to manage competing priorities, develop people, resolve compliance issues, and maintain inspection readiness in a fast-paced environment.

Key Responsibilities:

• Lead pharmacovigilance operations, ensuring accurate, complete, and timely processing and reporting of adverse events in accordance with Health Canada requirements and applicable global regulations.
• Oversee safety case assessment, quality review, reportability determination, regulatory submissions, literature surveillance, signal detection, PSURs, and Risk Management Plans.
• Lead PV audit and inspection readiness activities, including audit preparation, responses to findings, CAPA development, implementation, and effectiveness checks.
• Maintain and strengthen PV quality systems, including SOPs, work instructions, investigations, quality events, and risk mitigation strategies.
• Manage Pharmacovigilance Agreements with manufacturers and vendors, ensuring timely safety data exchange, reconciliation, and compliance with contractual and regulatory obligations.
• Lead PV training and awareness programs for internal teams and external partners.
• Oversee PV readiness for new product launches and collaborate with Quality Assurance, Regulatory Affairs, and other cross-functional stakeholders.
• Monitor PV KPIs, identify compliance risks and process gaps, and drive continuous improvement, workflow optimization, and database automation initiatives.
• Lead, coach, and develop the PV team while maintaining a strong culture of accountability, compliance, and patient safety.

Qualifications and Experience:

• Qualified Health Care Professional – good standing of a professional medical, nursing, pharmacist, or other health care practitioner association and entitled to provide health care under the laws of the jurisdiction in which the person is located and who have the appropriate health care education and therapeutic expertise Approximately 10 years of pharmacovigilance or drug safety experience, preferably within the pharmaceutical industry.
• Demonstrated experience leading or managing PV audits, inspection readiness, investigations, CAPAs, and remediation activities.
• Strong knowledge of Health Canada pharmacovigilance requirements, Canada Vigilance reporting, GVP, ICH guidelines, and applicable global PV regulations.
• Experience with safety databases, PV agreements, vendor oversight, PSURs, risk management, and safety surveillance.
• Experience in team leadership, training, KPI monitoring, and process improvement.
• PV database implementation, automation, and bilingual English/French capabilities are assets.