**Basic purpose of the job** Manage case processing activities for NBI’s investigational and marketed products including case submission to GPV and PMDA according to BI’s internal procedure and local regulation. Conduct safety risk management activities for assigned compounds by establishing and maintaining J-Risk Management Plan which fulfils compliance with BI’s internal procedures and local regulation Manage PV business operational tasks including SOP & Training and Quality Check of deliverables. Ensure quality of service level provided by vendor and maintain PV system **Accountabilities** Conduct case processing activities and case submission to Global Case Management and PMDA within reporting timeline Conduct dissemination of safety information including SUSARs and IND reports to study sites/investigators in collaboration with CD&O Set up case processing process for clinical trials including consultation with PMDA and coordination with supplier **Related performance indicators** In time ICSR reporting to GPV/PMDA ≧98% In time SUSARs/IND reports dissemination to study sites ≧98% Ensure in-time set up of case processing process Maintain PV database including system update according to BI’s strategy and international regulation **Related performance indicators** Ensure PV database updated and maintained Ensure communication of local safety profile of NBI’s investigational and marketed compounds to stake holders including GPSPV TA **Related performance indicators** Ensure global and local aligned risk management activities Develop and update J-RMP in close collaboration with GPSPV TA and ensure assessment of local safety profile of NBI’s products within assigned TA Implement and monitor risk minimization measures as necessary for assigned TA products at local level, coordinate safety issues with the local management, the regional PSPV Head and GPSPV **Related performance indicators** Ensure J-RMP timeline and quality Ensure global and local aligned risk management activities Ensure the preparation of local periodic safety reports and coordinate a review cycle with the global product responsible person at GPSPV for international products if appropriate **Related performance indicators** Ensure local periodi report preparation in time and provide quality documents Establish and support local inspection readiness, participate in PV audits and PV/GPSP inspections as required and contribute to CAPA processes as appropriate **Related performance indicators** Ensure local inspection readiness Conduct high-level trainings on regulations, global/ local PV SOP **Related performance indicators** Organize trainings to improve knowledge and skills of PSPV staff in cooperation with the corporate training function Prepare SOPs and WIs and Collaborate with other teams within PSPV or Clinical teams and Marketing teams on safety issues **Related performance indicators** Prepare SOPs, WIs and WMs satisfying Corporate SOPs and local regulations **Regulatory and / or Organisational Requirements** • Knowledge of local and international PV regulation • Knowledge of local and international NIS study **Job Complexity** Direct reports:0,Total Reports:0 **Interfaces** GPSPV, Primary care medicine, Specialty care medicine, CD&O, LRA, QM, BDS, MKT, SL **Job Expertise** ・3+years’ experience in pharmacovigilance **Job Impact** Conduct and Establish internal/external collaborations by sharing best practices **Minimum Education/Degree Requirements** Bachelors Degree　 **Required Capabilities (Skills, Experience, Competencies)** • Knowledge of local and international PV regulation • Knowledge of local and international NIS study • Excellent command of English language • Evaluation of safety information including individual case safety reports • Proactive and assertive attitude • Team- and networker **Recruiter : Tomatsu** All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.