Pharmacovigilance (PV) Training

Our safety team excels in providing a varity of pharmacovigilance (PV) training courses according to the needs of our clients. The courses are most updated, customized and integrated. We can create your own study packages based on your learning objectives. Sample courses are listed as follows. 

 

PV-INTRO

  • Organization of Global Safety Dept
  • Clinical Trials
  • Pharmacovigilance Theory & Definitions
  • The Roles and Interactions of Companies, Governments, and others 

 

PV-ICSR

  • AE/SAE Handling

 

PV-Coding

  • Coding
  • MedDRA point to consider

 

PV-Medical Review

  • Seriousness Assessment
  • Expectedness Assessment 
  • Causality Assessment
  • Drugs Safety in Special Groups
  • Clinical Trial Safety Monitoring
  • Post-Marketing Safety Monitoring

 

PV-Safety Data Analysis

  • Mathematics
  • Big Data Analysis
  • Data Mining
  • Signal Detection

 

PV-Risk Management

  • Risk and Risk Management and Assessment
  • Risk Specification
  • Risk Analysis
  • Risk Minimization

 

PV-Aggregate Report

  • Safety Report
  • DSUR
  • PSUR
  • PEBRA
  • Other Safety Aggregate Reports

 

 

 

 

G2 Strengths

  • US Based
  • 24/7 coverage
  • Safety expertise
  • Cost effective
  • Teamwork
  • Compliance-focused
  • Quality-driven
  • Timely turn-around
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