Cohortias – Benefits of Outsourcing Pharmacovigilance.

The implementation of an effective pharmacovigilance function is high on the list of priorities for pharmaceutical companies.

Outsourcing Pharmacovigilance

A pharmacovigilance outsourcing company should enable its clients to interact with one service provider for all the Pharmacovigilance (PV) and regulatory requirements.

The benefits of outsourcing include lower costs for staffing, recruitment, management, and training, along with access to resources in non-traditional, cost-effective regions. Sponsors also gain access to unique pharmacovigilance and patient safety expertise, intellectual property, multidisciplinary knowledge, and an unbiased view.

However, with stricter regulatory requirements, hiring experienced patient safety personnel is highly competitive.

Varying PV and safety regulations across the globe, new technologies, a wider range of patient safety indicators, and a higher demand for transparency all put continuous pressure on biotech and pharmaceutical companies.


As the demand for new therapies increases, so does the need to comply with regulatory requirements across the pharmaceutical industry, which is on the constant lookout for newer, more efficient ways to tackle the ever increasing load of adverse event data.

Sometimes the need is driven by a lack of availability of the necessary parts of the system to implement pharmacovigilance on time by first-time marketing authorization holders. Other times, it may be the need to streamline processes and reduce wastage by larger companies, in order to have a more robust and compliant reporting system.

More and more companies are looking at outsourcing as a possible solution to their short or long term needs.


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