Challenges in Global Pharmacovigilance – White Paper

The scenario of sustained business growth and diverse, evolving regulatory requirements to comply with across regions poses several unique challenges to the pharmacovigilance departments in Life Sciences companies.

In order to successfully function across multiple markets, life sciences companies must evolve their internal processes and systems to comply with diverse regulations effectively. Many organizations continuously optimize their pharmacovigilance practices in response to evolving market and regulatory requirements. Several organizations have completely outsourced their entire pharmacovigilance functions to dedicated service providers in anticipation of being able to benefit from economies of scale that vendors promise. Whatever be the case, the Pharmacovigilance departments today face several unique challenges. This paper will delve into some of these challenges and how they affect multiple roles within the pharmacovigilance and safety departments of life sciences organizations. It will also discuss how giving due consideration to certain specific factors will help pharmacovigilance departments to successfully meet their business expectations for now and for the future.

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