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Pharmacovigilance (PV) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines

The goals of PV are to bolster patient safety concerning medicine use by providing a system to collect, assess, and distribute drug safety data. PV activities involve monitoring approved drugs and investigational medicinal products (IMPs) to:

  • Identify previously unknown adverse effects
  • Recognize changes in the frequency or severity of known adverse effects
  • Assess the risk of a drug/benefit to determine if action is required to improve safety
  • Ensure the accuracy of information communicated to healthcare professionals and patients, and to ensure the information contained in patient information leaflets (PILs) is up to date.


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