Safety/Pharmacovigilance

Safety/Pharmacovigilance

By the time medicinal products are granted a marketing authorisation, knowledge about their safety is incomplete because the clinical trials investigating the safety profile and efficacy are usually performed with a relatively small number of subjects. The total number of adverse-event reports totalled 60,000 across Europe, according to a report from the European Medicines Agency. This figure highlights one of the key issues facing modern medicine, the need to track adverse events long after regulatory agencies have approved new drugs - enter pharmacovigilance. Typically, patients who want to report an adverse event are directed to their doctor, who can then relay that information to a pharmacovigilance data system. However, since only five percent of doctors are estimated to participate in any pharmacovigilance system, this process can be inefficient at cataloguing patient issues.

The German Medicines Act provides information obtained during the use of a medicinal product by after the marketing authorisation is granted. This is done for all finished products on the market in Germany and is the most important duty of the Pharmacovigilance Division. This Division continuously informs about the adverse drug reactions and interactions related to the use of medicinal products which have become known and ensures that patients, medical doctors and other interested parties are made aware of existing risks as well as of possibilities to decrease them. Education is the key to progress in the area of pharmacovigilance. According to a 2018 report by the World Health Organization, more than 50% of all medicines are prescribed, dispensed or sold inappropriately, and 50% of patients fail to take them correctly.

A bright future is assured for employees within the sector as the global pharmacovigilance market size is estimated to grow at a CAGR of above 12.8 % over the forecast time frame 2019-2026 and reach the market value around €9.5bn by 2026, according to Acumen Research.

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. Our expert consultants place talent in the safety/pharmacovigilance industry in Germany and across Europe.

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