Us Risk Management Expert

Profile

US Risk Management Expert

The candidate serve as the initial point contact for corporate development project teams at the time when US risk management strategies are being initiated for assigned products. Collaborate with the USRM Lead, CSH, Global Safety Officers, Regulatory, Medical Unit, etc. in the development, analysis and interpretation of study data to optimize the effective and safe use of firm and Genzyme products. Collaborate with Core Team to provide strategic input that is compliant and effectively links to the Business Unit needs for assigned products. Provide safety expertise in internal committees (e.g., Labeling Review Committee, Study and Protocol review committee, etc.) to ensure safety topics and risks are adequately addressed as reflects the Risk Management strategy and planning. Develop and communicate Risk Management strategies, including REMS, in conjunction with the USRM Lead and CSH, as well as the tactical minimization strategies, in support of all firm products. Direct cross functional teams (e.g. Transversal Team) to develop and implement risk communication strategies, leveraging informational and educational needs of customers into evidence based strategies and programs. Develop and implement a voluntary US Risk Management strategy. Contribute to the writing, coordination, review, approval and maintenance of the local RMP. Ensure communication of RMP and REMS to all relevant internal stakeholders and partner companies. Participate in the preparation of communication documents related to REMS activities to Health Care providers, Health Care Professionals, Patients, and experts in risk management. Responsible for maintaining up-to-date knowledge regarding concerned products, products environment, risk management methods and regulations. Surveillance of new or changing risk management communications, regulations and guidance from US FDA; communication of these relevant notifications to the Americas Region and/or Global Pharmacovigilance departments; oversee implementation of necessary changes in US risk management activities as warranted based upon this FDA Intelligence surveillance. Ensure compliance with safety-related post-marketing commitments to FDA, in collaboration with Quality Standards and Training team. Provide risk management expertise for interactions with the FDA and other customers, including inspections. Contribute to the optimization of standard operating procedures within the organization as regards local risk management activities, in collaboration with relevant internal teams. Monitoring the safety profile of assigned marketed products through early detection of potential safety signals and appropriate triage for further evaluation. Doctorate degree from an accredited college or university (e.g., M.D., J.D., PhD, PharmD, or equivalent) Area of specialization: MD (Board certification or eligibility) preferred; PhD or PharmD with risk management experience. MPH a plus.

Additional Information

Reference Id: R2474774

Company info

Sanofi Group
55 Corporate Drive
Bridgewater
New Jersey
United States 08807-5925
Website : https://www.sanofi.com/