Pharmacovigilance

As per WHO, pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems.

Adverse Event

An adverse event is any unwanted or unexpected sign, symptom or health problem that occurs during a medicine course or treatment. It does not have to be caused by the medicine, but reporting it helps determine whether there is a relationship between the event and the medicine.

Why Reporting Matters

Medicines are carefully tested before approval, but some side effects only become known after a medicine is widely used. Everyone’s body reacts differently; what is rare in clinical trials may appear once thousands of people use the medicine.
By reporting adverse events, you help us identify issues early, take action to protect patients and ensure that the benefits of medicines continue to outweigh the risks.

What Is the Minimum Amount of Information Needed for a Report?

  • An Identified Reporter
  • An Identifiable Patient
  • A Suspected Adverse Reaction
  • A Suspected Product

Adverse Event Reporting

Check all applicable seriousness criteria
Did the adverse reaction stop after stopping the drug?
Suspected Medicine Resulting in Adverse Reaction
Concomitant Drugs And History
Reporter Source

Strategic Partner