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

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.