Sanofi Group Risk Management Expert in Bridgewater, New Jersey
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 the US 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, in order to support and align the product strategy between Europe and US, taking into consideration the American specificities. In addition, this RME addresses any RMP related questions raising from America’s regions, and vice versa convey the global RMP Team any specific requirements of the FDA or the Latin American Agencies, that would impact on RMP activities more globally.
Knowledge And Skills:
Risk management 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
Formal Education :
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 Experience required
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
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 postmarketing settingto 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-RMSto 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 ouputs within sanofi:
- Communicates and promotes knowledge on regulation requirements, guidances, 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
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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