|部署・役職名||Associate Director, System Management, PMS|
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.
Realize the vision and mission of WWPS Japan and contribute to realizing better patients’ life through promoting the risk minimization and benefit maximization of our 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.
・Develop and disseminate an effective strategy to realize PS’s mission and vision.
・Ensure safety database safely and effectively in the alignment with our HQ.
・Optimize safety management processes along with the safety management strategy on Japan.
・Optimize standard systems and support for system functions along with strategy of PMS tasks
・Recruitment, resource assignment and talent development.
・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, develop and maintain the safety database system to assure the quality and stable of PV operations.
・Ensure stable use of safety database and relative problem solving.
As System Lead, introduce and develop operation process of safety database after implementation to maintain the quality of data that ・
・Reports to PMDA for Safety reporting.
・Support to implement new technology, and tools to make the business effectively to 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 old system MARS, and renews system including AE/Complaint/Malfunction reporting system PICRS.
・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.
・Perform process management for PV－related outsourcing.
・Graduate in Computer Science or Computer engineering or relevant mixture of qualifications and experience.
・B.S. in medical / pharmaceutical / life－science area （recommended）
・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 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）.
・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.
・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. Ability to 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）
Why You Should Apply
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.
We recognize 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.