• Provides independent assessment of risk-benefit of products
  • Review of target medical events and causality assessments
  • Develop and provide medical input to Periodic  Safety Reports (PSUR and PBRER) and Annual Safety Reports including Development Safety Update Report ( DSUR)
  • Develop andprovide medical input to Risk Management Plan
  • Contribute towards writing safety operating procedures
  • Facilitate compliance inspections and provide support with regulatory inspections
  • SUSAR submissions in compliance with regulatory requirements
  • Medical assessment of safety signals
  • Product Safety report
  • Assessment and Response to Regulatory safety inquires
  • Product Label
  • Versatile withOracle ARGUS, ARISg Global, AERS safety database