Pharmacovigilance

  • Pharmacovigilance System Master File (PSMF)
  • Operating procedures and work instructions
  • Maintenance of the quality management system that supports PhV activities
  • Local and international literature monitoring
  • ICSR (Individual Case Study Report) management
  • PSUR (Periodic safety update reports) and RMP (Risk Management Plan) elaboration
  • Signal Management
  • PhV training
  • Local QPPV
  • Audit and Inspection Support

 

 

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