pharmacovigilance outsourcing

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Why do pharmaceutical companies want to outsource their pharmacovigilance operation?

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Some pharmaceutical companies treat their drug safety surveillance activities as an exercise in compliance rather than as an integral part in ensuring the well-being of the patients taking their products. Pharmacovigilance can seem like a burden and a chore rather than a necessary part in running a pharmaceutical company. Yet the benefits of an effective pharmacovigilance department can often mean the difference between having a drug withdrawn from the market and having it stay. Companies that relegate pharmacovigilance to a distant second in terms of priority will often experience expensive crisis after expensive crisis that cost the company far more than effective pharmacovigilance – crises that would have been avoided if the pharmaceutical company took their responsibilities seriously.

However pharmacovigilance IS expensive. And pharmaceutical companies ARE companies and do have to make a profit, even the most responsible pharma company knows that it is answerable to its shareholders and stakeholders as well as the regulatory authorities.

So what to do?

Well one solution is to outsource some or all of the drug safety surveillance activities or to bring in consultants. Is this wise? Well it might be but it depends where the work goes and why the work is being outsourced in the first place.

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