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Years of Experience
Date Last Verified
ProfileRisk Management Lead The candidate will lead a team of country level risk management associates to develop and communicate local risk management activities as derived from the company core risk management strategy and plan which applies to all company products in the US. Direct cross functional teams providing collaboration and support for risk management initiatives and development of risk communication approaches and plans, leveraging informational and educational needs of customers into evidence based programs. The Lead of US Risk Management is responsible to: Serve as the departmental lead for the development and oversight of corporate development project teams at the time when US risk management adaptations of the company core risk management strategies are being initiated. Review and endorse the risk management strategy devised by the REMS officer. Lead a cross-functional team of risk management associates to assess the integration and implementation of REMS activities from other company entities, including Genzyme, Chattem and Pasteur into the company US Risk Management team. Ensure implementation of FDA-approved REMS in conjunction with the program vendors supporting the program. Provide safety expertise in internal committees to represent the local risk management plan implementation in the US and REMS implementation in the US. Direct cross functional teams providing collaboration and support for Risk Management activities whether part of the local risk management plan or REMS, leveraging informational and educational needs of customers into evidence based strategies and programs. Acquire full knowledge of the safety specifications and context motivating the company core RMP and REMS; consult appropriate experts and functions to propose local adaptations to a global Pharmacovigilance plan. Contribute to the writing, coordination, review, approval and maintenance of the local RMP and the local REMS. Ensure communication of RMP and REMS to all relevant internal stakeholders. Participate in the preparation of communication documents related to REMS activities to Health Care providers, Health Care Professionals, Patients, and Risk Management Associates. 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 GPE Stakeholders: Country Safety Lead/Regional Safety Lead and to GBU PV Groups, Risk Management Center of Excellence, Safety Regulatory Intelligence in Global PV Policy, Global Safety Sciences; oversee implementation of necessary changes in US risk management activities as warranted based upon this FDA Intelligence surveillance. Development and maintenance of Standard Operating Procedures (SOPs) around risk management and REMS activities. Ensure adequate training of US Pharmacovigilance personnel in US risk management and REMS processes. Ensure compliance with safety-related post-marketing commitments to FDA, in collaboration with Quality Standards and Training team. Provide risk management and REMS 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 and REMS, in collaboration with relevant internal teams. Lead a team of direct reports to ensure that all risk management issues across the US organization are handled proactively, when possible, and in a timely manner. Mentor, coach, and guide direct reports in individual development, leveraging and honing individual talents to best meet the business needs of the organization. Provide constructive feedback to promote consistent demonstration of company Values and Key Competencies expected for the individual’s specific title, roles, and responsibilities. Adapts the company core risk management strategy and plan to the US local risk management plan to ensure its implementation in the US. Coordinate and track its implementation. To work closely with the Global Safety Officers and Risk Management Experts and local medical teams to adapt the company core risk management strategy including local US specificities for products submitted for US approval. This position assumes significant networking within the local and global organization and at all levels in order to ensure that all information required is obtained and processed, and that all stakeholders contribute actively to the preparation and implementation of the risk management activities throughout the company. Development and maintenance of Quality Documents governing risk management activities in the US pharmacovigilance group. Assist in development and continuing update of the Risk Evaluation Mitigation Strategy Plan (REMS) for all company entities, leverage and act as the coordinator for risk management. This position assumes significant networking within the local and global organization and at all levels in order to ensure that all information required is obtained and processed, and that all stakeholders contribute actively to the preparation and implementation of the risk management activities throughout the company. Additionally, responsibilities include the development of strategic objectives for the oversight of risk assessment and risk management in the context of REMS and in the implementation of appropriate risk mitigation and communication plans for marketed/registered U.S. Products. Lead a cross-functional team to assess the integration of REMS activities from all company entities in the US and then implement the new processes. Close surveillance and implementation of new regulations and/or guidance issued by the US FDA related to REMS and Risk Management activities for products marketed in the US. Responsible for acting as a local sentinel supporting the global safety signal detection in coordination with the CSL. Responsible to review domestic ICSRs in order to identify any locally unanticipated trends and clusters of similar cases or pattern variances in product usage or relevant safety data at the earliest possible stage regardless of the source of the information. Responsible to investigate, any local cluster or trend to identify the underlying cause(s). Any local clusters or safety trends that represent a potential safety issue should be escalated to GPE for validation and further assessment.
Qualification and Experience
The candidate should have 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. Must have progressive experience in the Pharmaceutical or Biotech Industry working in in multiple areas including pre-clinical or clinical drug development, Pharmacovigilance, regulatory affairs, medical affairs, pharmaco-epidemiology, market research, health outcome research, within the pharmaceutical/medical device industry or a public health institution, totaling 7-10 years.