.png)
Pharmacovigilance Interview Questions and Answers
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
In Simple Words:
Pharmacovigilance is about monitoring the safety of medicines after they have been released in the market, to ensure they are not causing unexpected harm to patients.
Key Objectives of Pharmacovigilance:
Identify new adverse drug reactions (ADRs)
Monitor the frequency and severity of known ADRs
Improve patient safety
Promote safe and effective use of medicines
Provide data to help in regulatory decisions, such as changing dosage or even banning a drug if needed
Why is it Important?
Clinical trials can't detect all side effects (they're limited in time, size, and diversity of participants).
Once a drug is used by millions, rare or long-term side effects may emerge.
Pharmacovigilance helps protect public health by catching these problems early.
Examples of Pharmacovigilance Activities:
Collecting reports of side effects from healthcare professionals or patients
Analyzing trends in adverse effects
Updating drug labels with new warnings
Withdrawing harmful medicines from the market
Key Organizations Involved:.
WHO Uppsala Monitoring Centre (UMC)
US FDA
EMA (European Medicines Agency)
CDSCO (Central Drugs Standard Control Organization) – India