Operating A Pharmacovigilance Group In A Multicultural Global Environment

By Mark Vieder, Vice President, Drug Safety and Pharmacovigilance

In any clinical trial, the top priority for all stakeholders involved in the development of new drugs is to ensure that the products being studied are not only effective but safe for patients to use. It is the responsibility of the Drug Safety and Pharmacovigilance function within a research organization to ensure safety reporting is conducted in a timely, accurate, quality, and compliant manner.

Typical tasks of the Drug Safety and Pharmacovigilance team include, but are not limited to, Severe Adverse Event (SAE) / Adverse Event (AE) reporting and case management and analysis, medical monitoring, SAE/AE narrative writing, medical coding and drug validation. The successful execution of these tasks requires clear communication and smooth collaboration among team members. In an increasingly global, multicultural business environment, however, communication breakdowns can often arise.

This article will look at the approaches Drug Safety and Pharmacovigilance teams can take to resolve these issues, allowing the pharmaceutical industry to receive the benefits of operating in a multicultural environment.