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Pharmacovigilant (PV or PhV), also known as an affinity for drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilant" are: pharmakon(Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilant pertains specifically to one who is medically intuitive and aims to prevent adverse drug reactions or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. [Information] received from patients and healthcare providers via pharmacovigilant persons assist with creating agreements (PVAs), as well as other sources such as the medical literature, plays a [critical role] in providing the data necessary for pharmacovigilance to take place. Ultimately, pharmacovigilant is the ability to [anticipate] risk using intuition, data and the ability to identify previous triggers, negative outcomes and hazards [associated] with pharmaceutical products and practiced with the primary intent of honoring the risk vs benefit algorithm, and minimizing the risk of any harm that may come to patients. Companies must conduct a [comprehensive] drug safety and consult competent and qualified pharmacovigilant individuals to effectively audit and assess their compliance with worldwide laws, regulations, and guidance.
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