Gestionnaire principal(e), Pharmacovigilance Corporative/ Senior Manager, Corporate Pharmacovigilance

McKesson•Montreal, QC

4d•CA$97,700 - CA$162,800

About The Position

Reporting to the Director, Corporate Pharmacovigilance and Drug Safety, the Senior Manager, Corporate Pharmacovigilance provide strategic and operational leadership for McKesson Canada's pharmacovigilance and product safety programs. The role is accountable for ensuring compliance with Canadian and applicable international pharmacovigilance regulations for drugs, natural health products, medical devices, and other regulated health products marketed, distributed, imported, or supported by McKesson Canada and its affiliated businesses. The Senior Manager leads a team of pharmacovigilance professionals and oversees the implementation, maintenance, and continuous improvement of pharmacovigilance systems, processes, partnerships, and technologies. The role serves as a key partner to internal stakeholders and external business partners to ensure patient safety, regulatory compliance, inspection readiness, and operational excellence.

Requirements

M.D. Degree, or degree in pharmacy, nursing or related disciplines (Health Care Professional).
Minimum 10 years of progressively increasing responsibility in Pharmacovigilance, Drug Safety, Medical Information, Regulatory Affairs, Quality, or related healthcare industry functions.
Minimum 5 years leading teams and/or managing complex cross-functional programs.
Signal management and benefit-risk assessment.
Risk Management Plans and risk minimization activities.
Inspection and audit readiness.
Vendor oversight and governance.
Demonstrated ability to identify, evaluate, and champion the adoption of AI, automation, and digital transformation initiatives that enhance pharmacovigilance compliance, operational efficiency, inspection readiness, and business performance.
Knowledge of Health Canada, FDA, EMA, and ICH pharmacovigilance requirements.
Excellent verbal and written communication skills
Excellent attention to detail and accuracy maintaining consistently high-quality standards.
Bilingualism (French / English) is a requirement in this position.
Strategic thinking and business acumen.
Change management and organizational leadership.
Ability to influence stakeholders without direct authority.
Ability to lead cross-functional initiatives and organizational change.
Generates enthusiasm and drive for commitment to excellence
Strong system-thinking, analytical and problem-solving capabilities and skills.
Ability to conduct root analysis, proactively resolve issues and make sound decisions
Good interpersonal and negotiation skills
Leadership capacity for complex and strategically important projects
Understanding of legal and regulatory considerations impacting pharma/biotech industry and ability and judgement to apply principles to daily activities
Excellent clinical acumen and decision making
Understanding of contractual concepts and terminology
Demonstrated ability to coach, mentor and develop emerging leaders

Responsibilities

Support the development and lead execution of the pharmacovigilance strategy aligned with corporate objectives and regulatory requirements. Provide leadership and direction for long-term pharmacovigilance operational planning, resource management, and organizational development.
Implement and maintain governance processes and oversight mechanisms for PV activities across assigned business units and contracted partners.
Drive Quality PV organization to ensure processes optimization, safety data quality, and accurate regulatory reporting are aligned with regulations. Oversee the medical review, analysis, and guidance during the case handling and regulatory reporting.
Monitor emerging regulatory requirements and communicate potential impacts to the Director and relevant stakeholders.
Accountable for maintaining corporate PV compliance with company guidelines, legal and health authority regulatory requirements, and industry practices pertaining to PV. Monitor changes in Canadian and international pharmacovigilance regulations, guidance documents and industry best practices and recommend process improvements to maintain compliance.
Lead organizational initiatives to drive operational excellence in PV. Establish and monitor Key Compliance and Performance Indicators and metrics for PV team. Prepare and communicate management reports and scorecards related to the PV activities.
Coordinate and oversee signal detection and foreign regulatory authority monitoring activities and escalate significant safety concerns as appropriate.
Support the development, implementation, and maintenance of Risk Management Plans (RMPs) and risk minimization measures as required.
Accountable for identification, initiation, development and implementation of PV process improvements, tools, systems, and procedures to ensure quality and consistency in PV operations and contribute to the development, improvement and standardization of new processes and methods. Proactively identify procedural gaps and challenges and propose/implement solutions.
Oversee the development, implementation and maintenance of Standard Operation procedures, Work Instructions, Guidance, Policies etc... for PV ensuring consistency among applicable McKesson entities and alignment with Health Authorities requirements.
Develop, implement, and manage a corporate PV training program.
Develop, implement, and maintain a comprehensive pharmacovigilance compliance monitoring and self-inspection program to support ongoing inspection readiness.
Oversee the preparation for Health Canada inspections, regulatory authority inspections, and internal/external audits. Support interactions with regulatory authorities and participate in inspections, audits, and regulatory discussions as required. Oversee the development, implementation, and effectiveness verification of corrective and preventive actions (CAPAs).
Contribute to the preparation and review of periodic safety reports.
Establish and monitor performance metrics and governance mechanisms for third-party service providers and business partners. Ensure effective oversight and maintenance of Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs).
Serve as Safety Database Systems Owner. Ensure validated status, data integrity, security, business continuity, and compliance of all PV-related electronic systems. Lead system implementation, upgrades, validation activities, configuration management, and user governance.
Recruit, lead, develop, coach, and evaluate direct reports in accordance with the company’s HR policies and practices.
Knowledge of Artificial Intelligence (AI), automation technologies, and digital tools relevant to pharmacovigilance and medical information operations, including awareness of governance, compliance, data integrity, and validation considerations.
Lead the evaluation and implementation of pharmacovigilance technologies, automation solutions, artificial intelligence tools, and system enhancements to improve efficiency, compliance, and scalability.
Ensure high standards of PV compliance, ethics, and safety;
Effectively demonstrate strong leadership across all PV-related activities at McKesson Canada.
Recruit, develop, coach, and retain a high-performing team.
Establish clear performance expectations and development plans.
Foster a culture of accountability, continuous improvement, innovation, collaboration, and employee engagement.
Plan and allocate resources across all areas for assigned projects/programs.
Ensure business continuity plans are established and maintained for critical pharmacovigilance processes.
Could serve as a back-up person or SME in case of the absence of any PV&MI team member, to ensure the continuity of daily activities.