The primary function of this position is to serve as the US Pharmacovigilance Expert in US Risk Management activities, including:
· Close surveillance and implementation of new regulations and/or guidance issued by the US FDA and other Regulatory Agencies that may impact the Risk Management activities for products marketed in the US.
· To work in conjunction with the US Risk Management Lead (USRM Lead) and Country Safety Head (CSH)/Regional Safety Head in developing strategic objectives for the oversight of risk assessment and risk management and in the tactical design and implementation of appropriate risk mitigation and communication plans for marketed/registered U.S. products for Sanofi and Genzyme, with the GBU PV Groups, Global Risk Management , Safety Regulatory Intelligence in Global PV Policy, Global Safety Sciences, and others. Additionally, responsibilities include collaboration with the US Risk Management Lead and Country Safety Head/Regional Safety Head in the adaptation of the Global Risk Management Plan (RMP) to local US specificities for products submitted for U.S. approval.
· Signal Detection: Review the safety profile of assigned marketed products for Sanofi and Genzyme through early detection of potential safety signals and appropriate triage for further evaluation, collaborating with the Global Safety Officer/TA and the US Safety Management Team as appropriate.
Job Duties and Responsibilities
· 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 Sanofi 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 Sanofi 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. As a core member of the cross-functional REMS Oversight Committee (ROC), implement a REMS program where required.
· Acquire full knowledge of the safety specifications and context motivating an RMP and REMS; consult appropriate experts and functions to propose local adaptations to a global Pharmacovigilance plan or create a local RMP as needed. Defines a risk minimization strategy as needed.
· 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.
· Minimum of 3 years experience in the Pharmaceutical or Biotech Industry
· Knowledge/experience working in multiple areas including: pre-clinical/clinical drug development, pharmacovigilance, regulatory affairs, medical affairs, pharmaco-epidemiology, market research and health outcome research.
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.
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.