A Primer on Pharmacovigilance

March 26, 2018
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Pharmacovigilance may seem like a mouthful, so here’s a walk through of what it is really all about.

The term refers to the process of monitoring and improving the safety of medicines and therapies.

This discipline can be categorized into four areas, namely, operations, surveillance, systems, and QPPV.

For operations, those in the realm of drug safety start their career here, which involves collecting and recording information during the preclinical phase and in clinical trials. They also produce standard operating procedures and case study reports.

Surveillance involves data analysis on drug safety information gleaned from the wider division. They also engage in risk management and signal detection through creating safety update reports for drugs in clinical research.

The systems division is in charge of keeping safety data, which is typically available to all. Moreover, they keep abreast on complying with the ever changing regulations for business and health authorities.

Those who are in senior roles are most likely assigned to QPPV, which refers to qualified person for pharmacovigilance. They plan for the requirements that companies should follow.

All of us have taken medicines at least once in our life. You’ve probably complained of side effects, such as nausea or stomach pain from taking antibiotics. The official definition of side effect is an unwanted incident in response to the medicine taken. They are known by other terms, like adverse reactions.

Pharmacovigilance is important, because it’s all about patient safety. We read about news concerning serious conditions or even deaths resulting from taking a particular medicine or vaccine. This is where the system factors in. When it comes to healthcare and related industries, nothing could be more important that the patient’s health.

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