Canada Risk Management Lead

Reference No. R2836094

About the Job

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Lead the strategic development and implementation of risk management activities for Sanofi products in Canada, ensuring optimal benefit-risk profiles through data-driven decision making and cross-functional collaboration. Drive compliance with evolving Corporate and Canadian regulatory safety requirements while fostering innovation in risk minimization approaches.

This role offers flexibility for hybrid work arrangements in alignment with Sanofi's flexible work policies.

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities: 

Company Core Risk Management Strategy/Plan

• Evaluate submission dossiers to make strategic recommendations for Risk Management Plans (RMPs) specific to Canada

• Present the Canadian RMP position to cross-functional project teams, driving strategic decisions through data-driven insights

• Adapt global risk management strategies for the Canadian market by:

o   Coordinating and tracking its implementation using digital tools

o   Collaborating with Global Safety Officers (GSO), Risk Management Experts (RME), and local stakeholders.

• This position requires extensive collaboration across local and global teams at all organizational levels to ensure effective flow of information and active stakeholder engagement in the development and execution of risk management activities company wide.

• Develop and maintain Quality Documents governing risk management activities in Canada.

• Provide expert consultation to Global Risk Management Supervision Groups (GRM-SG) as needed, offering strategic input and Canadian regulatory perspective in the development of risk management strategies for new product launches.

Canadian RMP implementation

• Drive the development and implementation of Canadian RMPs across Sanofi portfolios using innovative digital platforms and analytics.

• Lead cross-functional initiatives to optimize risk management activities.

• Develop strategic objectives for the oversight of risk management and risk assessment in the context of Canadian RMP.

• Monitor and analyze the effectiveness of risk minimization measures using quantitative and qualitative metrics.

• Stay current with evolving Health Canada regulations and guidance, leading change management initiatives for new requirements.

• Develop innovative approaches for risk mitigation and effectiveness assessment.

• Influence the Canadian RMP landscape through evidence-based advocacy and stakeholder engagement.

Enhanced Safety Surveillance

• Oversee and participate in local safety surveillance activities for products with additional risk minimization measures (aRMM), evaluating effectiveness and identifying emerging safety concerns.

• Maintain knowledge of products and the Canadian regulatory landscape.

• Foster partnerships with patient advocacy groups and healthcare providers.

General responsibilities of the Canadian Risk Management Lead:

Strategic Leadership and Expertise

• Serve as the subject matter expert (SME) for risk management activities across all Sanofi products in Canada.

• Develop and communicate local risk management strategies aligned with global directive and Canadian regulatory requirements.

• Lead cross-functional teams to integrate and implement risk management plans (RMPs) across all Sanofi product in Canada.

Regulatory compliance and Stakeholder Management

• Ensure compliance with Health Canada-approved RMPs, collaborating with patient support program (PSP) vendors.

• Monitor and respond to evolving Health Canada regulations, guidance and communication related to risk management.

• Provide risk management expertise in interactions with Health Canada and during inspections or internal audits.

Cross-functional Collaboration and Communication

• Partner with global Risk Management Expert (RME) and local teams to develop and adapt risk management strategies for the Canadian market.

• Lead the preparation and coordinate the dissemination of RMP-related communications/tools to healthcare professionals, patients and internal stakeholders.

• Contribute to internal committee, representing local RMP implementation in Canada.

Process Optimization and Quality Assurance

• Develop, maintain and optimize Standard Operating Procedures (SOPs) for risk management activities.

• Create and update local RMP documents and implementation plans, ensuring global-level validation.

• Document and track the implementation of additional risk minimization measures (aRMM) using corporate tools (e.g., CaLIP application).

Safety Monitoring and Signal Detection

• Local monitoring of marketed products with aRMM.

• Lead early detection of potential local safety signals and coordinate appropriate evaluation and response.

Knowledge Management and Capacity Building

• Maintain up-to-date knowledge of Sanofi products, risk management methodologies and relevant regulations.

• Provide training and mentorship to stakeholders on risk management processes and responsibilities.

• Guide local PSPV colleagues in proactive and timely management of risk-related issues.

Innovation and Continuous improvement

• Leverage customer insights to develop evidence-based, educational risk management programs.

• Contribute to the ongoing optimization of risk management processes and strategies.

• Propose and implement local adaptation to global PV plans as needed.

The Canada Risk Management Lead may also assume the following key functions:

Safety Surveillance & Data Analysis

• Conduct local safety surveillance activities in accordance with Corporate and Canadian regulatory requirements.

• Provide expert medical review of aggregate safety data to identify trends and potential signals.

Crisis Management & Regulatory Response

• Address safety-related inquiries from diverse sources, including urgent Health Canada requests, product alert and crisis situations.

• Ensure timely compliance with safety-related post-marketing commitment in collaboration with the Regulatory Affairs team.

Product Lifecycle Management

• Contribute PV expertise to brand development throughout the product lifecycle.

• Participate in cross-functional product teams, integrating risk management perspectives into commercial strategies.

Cross-functional Collaboration

• Provide PV expertise and consultation to internal partners across business units.

• Foster a culture of safety awareness and regulatory compliance throughout the organization.

About You

Key requirements for this job

Education

• Pharmacy or Medical Degree: B. Pharm., B.Sc. Pharm., Pharm. D, MD. (Registered nurse with University degree or University degree in science and relevant experience and competency profile may be considered)

Experience

• 5+ years of pharmaceutical industry experience with 3+ years hands-on Risk Management experience

• Strong knowledge of pharmacovigilance regulatory process (mainly Health Canada)

• Experience with RMP development and implementation

• Experience with digital PV systems is an asset.

Specific skills and/or competencies

• Action-oriented, able to work with constant short deadlines

• Able to manage projects

• Strategic planning to achieve goals

• Skilled with computer applications

• Strong leadership and communication skills

• Excellent analytical and problem-solving abilities

• Excellent interpersonal skills

• Strong organization and priority setting skills

• Ability to focus on details where relevant whilst considering the global picture

• Resourceful and able to take ownership of areas of responsibility

• Cross-cultural communication and global collaboration abilities

• Change management and adaptability in rapidly evolving regulatory environment

• Continuous learning mindset and commitment to professional development

Languages

• French and English, written and spoken

Computer Knowledge

• Microsoft Office Suite, Pharmacovigilance databases

Why Choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness program

This position is for a current vacant role that we are actively hiring for.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

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