ドラッグセイフティー担当者/ スタッフorノンラインマネージャー/医薬開発本部ペイシェントセイフティー＆ファーマコビジランス部ドラッグセイフティーグループ
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