Job Description

Reference No. R2666113

Position Title: Risk Management Expert

Department: CoE Risk Management

Location: Mississauga

About Sanofi - www.sanofi.ca

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi entities in Canada include Sanofi Genzyme (Specialty Care), Sanofi Pasteur (Vaccines), General Medicines and Consumer Healthcare. Together we employ approximately 2,000 people. In 2019, we invested $131 million R&D in Canada, creating jobs, business and opportunity throughout the country.

Position Summary:

The RME provides risk management expertise for Sanofi products, especially for investigational products and/or high-risk profile marketed products and/or with complex regulatory / safety situations, elaborating risk management strategy and managing external interfaces with partners and/or regulators and/or other experts. He/she has a mentorship role for new RMEs or RMEs with less experience or fellowships.

The RME has an excellent capability, leadership and autonomy carrying out the missions and addressing major challenges detailed here-after:

Provides expertise & leadership in pre and post marketing risk management for investigational and marketed products supporting global, regional and local teams, aiming at patient safety.

Develops the global risk management strategies to optimize the benefit-risk profile, for initial submissions or marketed products in coordination with relevant functions (e.g. pharmacovigilance, epidemiology, medical, regulator, marketing/commercial) interacting with regulators or external experts, and ultimately obtains endorsement from appropriate senior committee(s).

Ensures development of RMP document (regulatory document of submission dossier) leading a cross-functional team (eg, RMP task force satellite of the product submission task force).

Supervises globally the appropriate implementation of risk minimization activities beyond routine for concerned products, using a validated electronic tracking system to monitor the local implementation data in collaboration with a cross functional team (regulatory, medical, pharmacovigilance and marketing/commercial).

Manages external interfaces with partners for investigational products and/or marketed products.

Participates as subject expert matter (SME) for risk management process to inspections/ audits.

Operates an oversight of the outsourced RMP related activities for concerned products or territories, as applicable.

Acts as primary contact or subject matter expert for the RMP Team on specific topics (e.g., SDEA or electronic tracking system or RMP related quality documents).

Delivers RMP trainings to internal and/or external audience.

The RME located in North America (NA) has a specific role of primary interface/liaison with the US Safety team dedicated to Risk Evaluation Mitigation Strategy (REMS) of products under development and marketed products, as well as the Canadian Risk Management Team. In addition, this RME addresses any RMP related questions raising from other America's regions, and vice versa conveys to the global RMP Team any specific requirements of the FDA/Health Canada or Latin American Agencies, that would impact on RMP activities more globally.

Key Responsibilities:

Risk management expertise for projects/products:

Provides expertise and support to internal or external team representatives for elaboration of the company core risk management strategy (CC-RMS) for products at all stages of the product life-cycle (development and post marketing phases). In particular:

Provides expertise in risk management including: risk characterization and impacts of risks, risk assessment, risk minimization and measurement of the effectiveness of risk minimization activities.

Determines the appropriate risk minimization measures in post marketing setting to ensure patient safety in light of benefit/risk assessment in coordination with relevant functions (pharmacovigilance, epidemiology, medical, regulatory), including at the local level. It encompasses interface with external experts as needed.

Obtains endorsement of CC-RMS by appropriate senior committees.

Ensures development of RMP documents leading a cross-functional team in frame of RMP Submission task force and/or RMP Working Group.

Ensures consistency/alignment of product CC-RMS across countries.

Provides support to local safety teams in developing and validating local RMP as appropriate.

Provides contribution to Health Authorities' questions, and participates to meetings and interacts with regulators to defend/negotiate the CC-RMS (as needed).

Provides expertise and supports to GSOs on Development Risk Management Plans.

Supervision of the implementation of additional risk minimization measures beyond routine (aRMMs) for concerned marketed products

Communicates product CC-RMS to appropriate audience.

Creates and leads the supervision group involving transversal functions in charge of global supervision of implementation of activities, executed and tracked locally.

Uses the validated electronic tracking system to validate and supervise local implementation plans.

Ensures follow-up of effectiveness of minimization activities, analyzes deviations and sets up adequate action plan for adjustment of the RMS as needed.

Maintains a high level of quality and knowledge on RMP-related activities and outputs within sanofi

Communicates and promotes knowledge on regulation requirements, guidance's, recommendations and templates with respect to risk management.

Ensures audits and inspections readiness for products at all stages of the life-cycle.

Ensures risk management governance process is applied.

Internal and external communication/network

Ensures networking with different internal stakeholders at global, regional and local level.

Ensures appropriate partners are informed about product RMP-related activities (as per Safety Data Exchange Agreement).

Ensures with medical affairs colleagues appropriate selection of vendors and establishes communication with external contract organizations developing minimization tools, with feasibility survey and/or user testing when needed.

Sets up or participates to medical/scientific expert meeting (internal/external) to determine adequate product CC-RMS.

Advocates risk management to internal and/or external stakeholders.

Risk management training and mentoring

Ensures training of GPV staff in risk management.

Collaboration and knowledge/experience sharing within RMP Team or GPV.

Mentorship of new RME comers or RMEs with less experience.

Provide external training as appropriate.

Key Requirements:

M.D., Pharm D, PhD or MPH Degree in pharmacovigilance and/or relevant medical field (e.g., clinical development) and/or regulatory area and/or toxicologist and/or pharmacoepidemiology.

Significant experience (including industry experience) with a working knowledge of drug safety and risk management, and understanding of life-cycle product, and specific knowledge of international RMP regulatory guidelines.

Working knowledge of common data processing software (i.e., Excel, PowerPoint, Word) or internal software's and database systems.

Technical skills for understanding document management systems including assembly of document.

Excellent understanding of the concept of risk associated with the use by patients of a medicinal product/medical device, in its clinical, individual patient health, public health and regulatory dimensions.

Strong knowledge of international regulatory and scientific environment in risk management (eg, international guidelines, RMP template).

Expertise in pre and post marketing risk management, including risk assessment and risk minimization activities with ability to propose strategies adapted to the product and the environment.

Expertise for supervising global and local implementation of risk minimization activities, particularly risk minimization activities beyond routine (e.g, educational material or controlled dispensing), and for analyzing effectiveness results of these activities in order to adjust the risk minimization strategy (as needed).

Excellent networking and collaboration skills to interact transversally with numerous functions involved in RMP-related activities, demonstrating leadership within a cross-functional team, as well as supporting local safety teams for developing local RMP documents.

Ability to share risk management knowledge, as a SME in that field

Ability to manage internal/external stakeholders with courtesy and respect.

Ability to present the risk management strategy to various internal committees.

Ability to discuss the risk management strategy with regulators (e.g. Agency meetings).

Demonstrates initiative and capacity to work under pressure, to contribute to solutions of safety crisis.

Strong ability to manage competing priorities and timelines for numerous products in parallel.

Fluent in English.

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.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.