Pharmacovigilance


Pharmacovigilance defined as the study of activities which relate to the detection, assessment, understanding and prevention of adverse effects. Pharmacovigilance is public health function and study of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines and also a key to drug safety. PV analysis evaluated in Phase I, Phase II, and Phase III a clinical trial which provides drug companies data on the safety assurance of the drug. The aim of pharmacovigilance in industrial areas are essentially the same as those of regulatory agencies; which is to protect patients from unnecessary harm by identifying previously unrecognised drug hazards, refuting false safety signals and quantifying risk to benefit.

  • Case narrative
  • Coding of adverse reaction descriptions
  • Coding of drugs
  • Case causality assessment

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