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Drug Safety Specialist/Non-Line Manager or Staff/Patient Safety and Pharmacovigilance

Basic Purpose of Job

  • Manage case processing activities for Nippon Boehringer Ingelheim’s investigational and marketed products including case submission to Global Patient Safety and Pharmacovigilance (PSPV) and PMDA according to Boehringer Ingelheim (BI)’s internal procedure and local regulation.
  • Conduct safety risk management activities, prepare and submit periodic safety reports and develop and maintain the safety part of local package inserts for the assigned compounds ensuring compliance with BI’s internal procedures and local regulation
  • Contribute to local asset team as an expert of benefit risk of the assigned compounds.

 

Accountabilities

  • Conduct case processing activities and case submission to Global Case Management and PMDA within reporting timeline
    Related performance indicators: In time Individual Case Safety Report (ICSR) reporting to GPV/PMDA ≧98%
  • Conduct dissemination of safety information including SUSARs and IND reports to study sites/investigators in collaboration with Clinical Development Operations (CDO)
    Related performance indicators: In time SUSARs/IND reports dissemination to study sites ≧98%
  • Set up case processing process for clinical trials including consultation with PMDA and coordination with CRO
    Related performance indicators: 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 stakeholders including Asset Benefit Risk Team (ABRT) Chair
    Related performance indicators: Ensure global and local aligned risk management activities
  • Develop and update Japanese Risk Management Plan (J-RMP) in close collaboration with ABRT Chair and ensure assessment of local safety profile of Nippon Boehringer Ingelheim’s products
    Related performance indicators: Ensure J-RMP timeline and quality
  • Implement and monitor risk minimization measures as necessary for assigned products at local level, coordinate safety issues with the local management and Global PSPV
    Related performance indicators: Ensure global and local aligned risk management activities
  • Ensure the preparation of local periodic safety reports and coordinate a review cycle with the ABRT Chair
    Related performance indicators: Ensure local periodic report preparation in time and provide qualified documents
  • Establish and support local inspection readiness, participate in PSPV audits and PV/GPSP inspections as required and contribute to CAPA processes as appropriate
    Related performance indicators: Ensure local inspection readiness
  • Prepare and review SOPs and WIs and Collaborate with other teams on safety related processes
    Related performance indicators: 'Ensure SOPs, WIs and KMEDs satisfying Corporate SOPs and local regulations
  • Coordinate revision of J-PIs (Japanese Package Inserts) according to CCDSs (Company Core Data Sheets) which Boehringer Ingelheim Corporate develops to harmonize J-PIs with global safety information
    Related performance indicators: Ensure CCDS compliance in a timely manner
  • Take necessary measures, such as the revision of J-PIs, to ensure patient safety based on the requests/ instructions from the authorities (MHLW, PMDA), and provide safety information to the medical institutions adequately
    Related performance indicators: Ensure J-PI timeline and quality
  • Plan and report for “Early Post-marketing Phase Vigilance” (EPPV) and safety risk communication
    Related performance indicators: Ensure quality of EPPV activities and risk communication

 

Regulatory and/or organizational requirements

  • Knowledge of local and international PV regulation
  • Knowledge of local and international study

 

Interfaces

  • Global Patient Safety & Pharmacovigilance, Clinical Development and Medical Affairs, Clinical Development Operations, Regulatory Affairs, Experimental Medicine, Commercial Quality, Marketing, Sales, Marketing Supervisor General, Medical Director

 

Job Expertise

  • TA experience in research or industry setting
  • 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)

  • Excellent command of English language
  • Evaluation of safety information including individual case safety reports
  • Proactive and assertive attitude
  • Team- and networker

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