Associate Director, System 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. Division Research and Development / Global Regulatory & Safety Sciences / Worldwide Patient Safety / Patient Safety Japan Functional Area Description The Worldwide Patient Safety Japan is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements. 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. Accurately grasp sources of information and stakeholders, establish an information acquisition system, and collect data comprehensively. Analyzing information without exception from a scientific point of view. Prioritize the interests of the patient. When accomplish safety administration duties; of comply with GVP-GPSP regulations, and make the decision making that thought that contribute to medical environment. To transmit scientific evidence to the healthcare providers setting quickly, and to carry out ensuring safety measures quickly.　 Position Responsibilities Develop and disseminate an effective strategy to realize PS’s mission and vision. Upgrade and maintain AWARE-J safety global database safely and effectively in the alignment with BMS HQ Plan to optimize safety management processes along with the safety management strategy on BMS-Japan. Plan to optimize safety management processes and scopes by outsources/vendors along with the safety management strategy on BMS-Japan. Optimize standard systems for PMS and support for system functions along with strategy of future PMS Support for activities for PA from the perspective of system development Recruit and assign right talents and develop them. Nurture healthy organizational culture and common values. Secure smooth operation through effective communications with external/internal stakeholders. (Including scope of entire roles and responsibilities, business impact of the job on the end results, consequences of errors, degree of relationship with global team, geographic/cultural/stakeholder scope and degree of supervision/guidance received. Maximize organization/team/individual performance (Evaluation/coaching/motivation/work environment optimization), include factors in case of team/project management as a leader.) As Head of a System management manager, to perform stable use of AWARE-J and develop and maintain the system to assure the quality and stable of PV operations Solution to the problem for stable use of AWARE-J: Argus-J management and problem solving, Development and implementation of quality management system for processes and deliverables. As System Lead, introduce and develop operation process of AWARE-J after implementation and develop and maintain the quality of data which BMSKK reports to PMDA for Safety reporting. Support to implement new technology, and tools to make the business effectively to PA&PV users. To prepare plans, adjustment, and implementation of new projects which are aligned with GPV&E for more effective case processing. Pushes forward the retirement of the existing system such as AE reporting system, and renews those types of Safety DB to create AE/Complaint/Malfunction reporting system (PICRS) and maintain the system, and upgrade of the system. Advises and supports the standardization of PMS databases for future use i.e. supporting for implementation of PMS databases and sharing of common master databases among PA & PV, and other departments. Implement more flexible development way of ad-hoc reporting to users. Identifies the best tool and implements it to collect voluminous data from MR to PV, i.e. CRF image data. Perform outsourcing management and process management to the PA&PV-related outsourcing, and develop and maintain the process to assure the quality and stable of PA&PV operations Degree Requirements Qualified person such as information processing engineer official approval B.S. in medical / pharmaceutical / veterinarian / life-science area is mandatory. Licensed pharmacist is preferable. Experience Requirements 5 years or more experience to interact with global counterpart(s) in a working environment. 5 years or more experience in general safety management division. 5 years or more experiences in supervising three or more member team, either as direct repots or multi-layer. 5 years or more experience in maintaining safety data management. Key Competency Requirements Knowledge Knowledge about Medical Information activities in Japanese industry including the role of Medical Representatives, expected contents and level among HCP. 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 Pharmaceutical and Medical Device Act, Fair Competition Code (FCC), Promotion Code, and any other applicable regulations in Japan. Knowledge about Global PV Guideline (ICH-Ex). Skills General skills of project management including schedule, budget, quality and issue. Communication skills as a professional in Japanese context as well as in global community, both internally and externally. Team management skills to lead a team, develop talents, nurture trust and confidence among members, and identify and address issues in a team. Evaluate the capability of the CRO under the objective systems, and maximize their ability. Language proficiency Complete level of written Japanese – can completely understand medical articles and general business documents in Japanese, can write and proofread formal Japanese at business setting. Complete level of oral Japanese – can have medical and scientific discussions and can communicate in an appropriate manner with internal and external stakeholders Advanced level of written English as non-native – can understand medical articles and general business documents in English without dictionary, can develop a document for any kind of job-related topics including complex ones. Advanced level as non-native speaker of oral English. OPA minimum 7.0 – can discuss, negotiate and persuade in English within the responsible job-related topics, can represent BMSKK Pharmacovigilance Japan in a global meeting Travel Required (nature and frequency). Nature and frequency, if required (Travel Required and overnight) 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.