Senior Manager, Safety Operations, Case Management

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Position Summary Realize the vision and mission of WWPS Japan and contribute to realizing better patients’ life through promoting the risk minimization and benefit maximization of the BMS products (drugs and regenerative products) by securing the safety of the patient. In order to implement safety management of products on a risk basis, the Mission is to analyze the collected safety information scientifically and take appropriate measures based on prompt decision making with ethics. In carrying out safety management work, adhere to regulations, make decisions that contribute to the medical environment, and make patient benefits the highest priority with unwavering integrity. The expected role and responsibilities for Safety Operations, Case Management are to process Japan’s Individual case safety reporting (ICSR) process and aggregate safety information and to report to PMDA in compliance with PV regulations as a member of PS (Worldwide Patient Safety）. Then, it is to contribute to achieve Scientific Excellence and Operational Excellence by analyzing the safety information with unyielding integrity. Evaluate necessarily of safety assurance measures of the BMS product on the scientific standpoint through developing safety aggregate report in cooperation with BMS-HQ. Develop/maintain the safety information management system within BMSKK and run it smoothly and appropriately. And to develop/maintain the PV system to assure the quality of PV operations. Position Responsibilities Evaluate necessarily of safety assurance measures of the BMS product on the scientific standpoint through developing safety aggregate report in cooperation with BMS-HQ. Develop/maintain the safety information management system within BMSKK and run it smoothly and appropriately. And to develop/maintain the PV system to assure the quality of PV operations. Evaluate necessarily of safety assurance measures of the BMS product on the scientific standpoint through developing safety aggregate report in cooperation with BMS-HQ. Develop/maintain the safety information management system within BMSKK and run it smoothly and appropriately. And to develop/maintain the PV system to assure the quality of PV operations. Collection of safety management information: The following safety management information shall be collected, evaluated and records thereof shall be prepared. Information from health professionals, information on reports presented at scientific meetings, from the literature, the health Authorities, and other safety management information. Evaluate necessarily of safety assurance measures based on examination of safety management information and the results thereof. Adverse Drug Reaction and Infectious Disease Reporting System: The collection and examination of Japanese and overseas drug safety information, as well as the adoption of specific measures based on this information, must be carried out in accordance with GVP-SOPs. The Enforcement Regulations for reporting adverse drug reactions specify reporting without late reporting. Analyze collected safety information on the scientific standpoint and report to HA as the periodically safety aggregate report. Quality Management: Delivery and monitoring of development and implementation of quality management PV system for processes and deliverables within GPV&E. Knowledge Management: Sharing and clarification of knowledge by converting individually owned implicit knowledge into explicit knowledge, and acceleration of the operational efficiency and innovation. Determine the new process with Global Safety Operations counter persons. To collaborate and manage contracted CRO venders for developing the new process of ICSR to PMDA without late reporting Degree Requirements University or master degree, Bachelor of Science, Master of Science necessary Experience Requirements Three years or more experience to process ISCR and aggregate report. Three years or more experience to interact with global counterpart(s) in a working environment. Three years or more experiences in supervising three or more member team, either as direct repots or multi-layer. Key Competency Requirements Knowledge Knowledge about Medical Information activities in Japanese industry including the role of Medical Representatives, requirements from HCP and its level. Basic knowledge about product-related data scheme including phases and composition of clinical development, characteristics of data from Japanese EPPV and PMS, Architecture of Common Technical Document etc. Knowledge about PMD Act., Fair Competition Code (FCC), Promotion Code, and any other applicable regulations in Japan. Knowledge about Global PV Guideline (ICH-Ex). Knowledge about Health Authorities’ inspections on GVP/GPSP. Skills General skills of project management including schedule management, budget management, quality management and problem solving. Effective negotiation skills for doing business smoothly. Team management skills to lead a team, develop talents, nurture trust and confidence among members, and identify and address issues in a team. Communication &Language skills Native level of written Japanese as native – can completely understand medical articles and general business documents in Japanese, can write and proofread formal Japanese at business setting. Native level of oral Japanese as native level – can have medical and scientific discussions and can communicate in an appropriate manner with internal and external stakeholders Advanced intermediated level of written English as non-native – can understand medical articles and general business documents in English without dictionary. Advanced intermediated level as non-native speaker of oral English. OPA minimum 6.0 – can participate to discuss in English within the responsible job-related topics in a global meeting Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.