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Pharmacovigilance (PV or PhV), also known as drug safety, is relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance focuses on Adverse Drug Reactions.
Information received from patients and healthcare providers via pharmacovigilance and medical literature, plays a critical role in providing the data necessary for pharmacovigilance. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by pharmaceutical company is required to be submitted to the local drug regulatory authority.
Thus, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.