Pharmacovigilance

Pharmaceutical physicians are responsible for a company’s pharmacovigilance activities (ensuring that a medicine continues to be safely and effectively used in society) and consult on the implementation of phase IV clinical studies. Once a marketing authorisation for a new medicine is granted and the product is made available to a wider patient group than the clinical trials programme, post-marketing utilisation with appropriate and safe prescribing needs to be closely monitored. As part of this life cycle management of the medicine and the continuing understanding of its scientific profile, the company will consider developing new indications, applications and dosage forms. Further studies may be required for other reasons – eg testing for interactions with other medicines, or on certain population groups such as pregnant women.

Pharmaceutical physicians responsible for drug safety work closely with clinicians and pharmacists to ensure full, timely and complete analysis of unexpected adverse drug reactions alongside the regulatory agencies, to comply with their necessary reporting regulations (for instance the yellow card scheme run by the MHRA). They also receive, investigate and act upon quality complaints for products, which might in some circumstances result in the removal of a batch of the product from the market, in the interests of safety and protection of patients.


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30/06/2018