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EPharma Global

EPharma Global

EPharma Global

Pharmacovigilance Associate

 


Duration: 40 CPD Hours

 

Course description:

Designed for those that have none or very little experience of in the field of clinical research (BSc or Post Graduate qualification required- Nursing or Science). This course is comprehensive and supports those seeking a position within the industry in Drug Safety. Following completion of this course you will be able to work effectively as a member of the Drug Safety Teams within organisations. You will gain a firm knowledge and understanding of key legislation applicable to Pharmacovigilance globally. Estimated completion time 40 hours on-line.

Elements covered in this course:

  • Drug safety and monitoring
  • Laws in Pharmacovigilance
  • Signal generation and detection
  • Spontaneous Reports
  • Good Reporting Practices
  • Case Report Forms
  • Case Series
  • Descriptive Analysis of a Case Series
  • Data Mining and Statistical Analysis
  • Non-randomised Observational Studies
  • Risk Management Training
  • Pharmacovigilance Plan
  • Further Laws & Guidance in Pharmacovigilance
  • Guidelines on Good Pharmacovigilance Practice
  • Adverse Events
  • Adverse Drug Reactions
  • General Reporting Time-lines for AE’s/SAE’s
  • CIOMS, ICH, ISoP, WHO

 

Enrol for Pharmacovigilance training

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Pharmaceutical Training’ in Clinical Research for:
Science and Nursing graduates/post graduates to train as Clinical Research Associates (CRA), Clinical Project Managers (CPM), Pharmacovigilance Associates (Drug Safety) and to gain knowledge in Good Clinical Practice and Audit Preparation and Response