Operational support

iVigee’s experts provide strategic advice and risk management services in a broad range of areas for your safety-systems-related operations, applying our decades of experience and utilizing iViReg, our cutting-edge regulatory intelligence tool for true global compliance.

Consult with iVigee if you need specialised support for:

  • Automation tools for case intake, including our new iViMedic call processor.
  • Fully automated expedited report scheduling and submissions to agencies and partners.
  • Workflow optimization and case priority design.
  • Auto-generation of case narratives, integrating case data with preferred text.
  • Assessing how U.S. and European pharmacovigilance regulations affect system management.
  • Safety system implementation and change management process oversight.
  • Argus 8.4.x upgrade for continued Oracle support.

Our iViSight intelligence tool includes:

  • Periodic benefit-risk evaluation reports (PBRER)
  • Development safety update reports (DSUR)
  • Clinical data and product complaint reconciliation reports
  • Signal detection listings, tabulations and dashboards
  • Workflow and operational productivity and compliance metrics
  • Daily or hourly line listings to support workload management and submission compliance
  • Auto-scheduled recurring reports delivered to target audiences at predetermined intervals
  • Ad hoc reports with quick turnaround
  • Experience with various reporting tools including comprehensive visualization of compliance and metrics data via Oracle Business Intelligence Enterprise Edition (OBIEE) dashboards, notifications and alerts.
  • Rigorous report validation process that ensures all analytic deliverables have been validated via suitable mechanism per intended business use.