Pharmacovigilance (PV)

    In Safety & pharmacovigilance

    Also known as: drug safety

    Pharmacovigilance is the science and practice of detecting, assessing, understanding, and preventing harm from medicines. It runs from first-in-human trials through the entire time a product is on the market. Trial safety reporting is one part of it; signal detection, periodic reports, and risk management are others.

    Why it matters

    Pharmacovigilance is one of the most portable careers in the field: the case-handling and coding skills are the same whether the product is a trial drug or a marketed medicine.

    Example

    A PV associate receives a report of an unexpected liver injury, enters it into the safety database, codes it with MedDRA, and checks whether the case meets the criteria for expedited reporting.

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