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Pharmacovigilance

Yongzheng provides pharmacovigilance full-service over the product’s lifecycle.

 

Backing/Boost corporate’s PV Self-development

 

Consultation + Customized Service + Training + Audit

 

We work closely with partner to develop corporate’s unique PV strategy, system and process based on its development stage and future blueprint and provide systematic training, unique joint talent training mode and timely audit to ensure the sustainable development of its PV business.

 

Service Scope

  • Individual Case Safety Report (ICSR) handling - Entry, Encoding, Assessment & Submission Literature search, review and AE screening           

  • Aggregate reports (DSUR, PSUR/PBRER, DSR and other summary reports) preparation           

  • Signal Monitoring           

  • Risk Minimization Plan           

  • Drug Key Monitoring/Intense Drug Monitoring           

  • PV documents’ preparation for license renewal           

  • Review safety contents in labeling           

  • Social interactive media AE monitoring           

  • 3rd party PV management