Pharmacovigilance Leader (Level commensurate with experience)
Mississauga, Ontario, Canada
Full Time (Hybrid)
About Mint Pharmaceuticals: Mint Pharmaceuticals is a Canadian pharmaceutical company recognized for its commitment to quality, compliance, innovation, and patient safety. Through our growing portfolio and strategic partnerships, we strive to make healthcare more accessible while upholding the highest standards of pharmaceutical excellence.
As we continue to expand, we are seeking exceptional leaders who are passionate about advancing healthcare, driving operational excellence, and building high-performing teams that make a lasting impact on patients, customers, and the healthcare community.
Position Summary
Reporting to the Vice President, Quality & Pharmacovigilance, Pharmacovigilance Leader will provide strategic leadership and operational oversight of Mint's global Pharmacovigilance system. This incumbent will serve as the company's Pharmacovigilance Subject Matter Expert and primary PV contact for business partners, vendors, and internal stakeholders.
The incumbent will drive compliance, inspection readiness, safety surveillance, signal management, aggregate reporting, Risk Management Plans (RMPs), foreign action notifications, Access to Information requests, and continuous improvement initiatives across the Pharmacovigilance function.
Key Responsibilities
Leadership & Compliance
- Lead and oversee Mint's Pharmacovigilance program.
- Maintain and continuously improve the PV Quality Management System.
- Provide strategic PV guidance to senior leadership.
- Ensure ongoing inspection readiness and regulatory compliance.
- Support product launches, acquisitions, licensing agreements, and business development activities.
Safety Operations
- Oversee adverse event, literature, medical inquiry, and product quality complaint processing.
- Ensure timely submission of ICSRs and regulatory safety reports.
- Maintain oversight of safety databases, coding practices, and reconciliation activities.
- Ensure compliance with regulatory reporting timelines and data integrity requirements.
Signal Management & Risk Management
- Lead signal detection, evaluation, and benefit-risk assessments.
- Develop and maintain Risk Management Plans (RMPs).
- Evaluate emerging safety issues and implement risk mitigation strategies.
- Collaborate on safety communications and product labeling updates.
Health Authority Interactions
- Oversee PSURs, PBRERs, Annual Summary Reports, and aggregate safety reporting.
- Serve as the primary Pharmacovigilance contact for Health Canada.
- Lead inspections, audits, regulatory inquiries, and agency responses.
- Monitor evolving Canadian PV requirements and implement changes as needed.
Regulatory Intelligence & PV Governance
- Manage Foreign Action Notifications and regulatory intelligence activities.
- Support Access to Information requests and regulatory transparency initiatives.
- Establish and maintain Safety Data Exchange Agreements and Pharmacovigilance Agreements.
- Develop and maintain PV Business Continuity and Disaster Recovery Plans to ensure uninterrupted operations and regulatory compliance during business disruptions.
People Leadership
- Lead, mentor, and develop a high-performing Pharmacovigilance team.
- Support talent development, succession planning, and training initiatives.
- Foster a culture of compliance, accountability, collaboration, and continuous improvement.
Qualifications
- Degree in Pharmacy, Nursing, Medicine, Dentistry, or related healthcare discipline.
- Qualified Healthcare Professional (QHP) designation preferred.
- 5-10 years of Canadian Pharmacovigilance, Drug Safety, Medical Information, or related pharmaceutical industry experience.
- Minimum 5 years of leadership experience within Pharmacovigilance or a regulated healthcare environment.
- Strong working knowledge of Health Canada, FDA, EMA, and ICH Pharmacovigilance requirements.
- Experience with safety databases such as Veeva Vault Safety, Argus Safety, or ARISg is preferred.
- Bilingual English/French is considered an asset.
Why Join Mint?
- Opportunity to build and shape a growing global Pharmacovigilance function.
- High visibility role with direct interaction with senior leadership and health authorities.
- Collaborative and dynamic environment where your contributions make a measurable impact.
- Competitive compensation package and professional development opportunities.
- Hybrid work environment based in Mississauga, Ontario.
Apply Today
- If you are a passionate Pharmacovigilance leader looking to make a meaningful impact on patient safety while helping shape the future of a growing Canadian pharmaceutical company, we would love to hear from you.
- Apply through LinkedIn or submit your resume to poonamp@mintpharma.com
Compensation & Benefits
Salary Range: Commensurate with level.
