How to Successfully Outsource your Pharmacovigilance

December 31, 2020

Pharmacovigilance has always been an integral part of drug development. The origins of pharmacovigilance go as far back as 170 years, when medical community of that time started trying to understand the side effects of the used drugs in order to protect patients.

In the last decades pharmacovigilance practices and systems across the globe are changing rapidly significantly due to technological innovations, massive amount of data to review and analyze for biopharmaceutical companies and competent authorities, as well as the increasing importance of patient-centric approach¹. As a result, pressure for compliance placed upon the pharmaceutical industry has drastically increased during this time.

Key trends in Pharmacovigilance:

  • Safety documentation and drug approval reviews have become more complex due to the ever-growing volumes of data collected
  • Public awareness about adverse drug reactions has increased making drug safety an even greater priority to consumers, industry and regulators
  • Safety concerns have led to worldwide requirements for significantly more detailed product information. Companies are now under more pressure to publicly display all safety-related data transparently.

The challenge that this presents…

More than ever, the biopharmaceutical industry is in need of powerful systems compliant with current requirements. This demands time and resource of highly experienced industry professionals. As such, companies today look for cost-effective ways to maintain all aspects of pharmacovigilance infrastructure and remain competitive, whilst the ongoing pandemic complicates the situation. This is where pharmacovigilance partners come in.

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Outsourcing pharmacovigilance:

There are a number of things you must take into consideration in pharmacovigilance outsourcing:

  • Choose a partner who keeps track of the industry changes and adapts their systems and practices accordingly
  • Ensure that your pharmacovigilance partner will provide a dedicated contact for you to reach and is responsive: smooth communication and fast turnaround is key when patient safety is at stake
  • Ensure that your partner has a zero-tolerance attitude to mistakes and a record that backs this up.

About Dokumeds:

  • Dokumeds offers a range of pharmacovigilance services from complete to separate functional services. In each case, you will be assigned a dedicated and highly experienced team
  • We ensure the highest standards of patient safety at every stage of drug lifecycle
  • We have over 25 years of experience in the industry. We stay on top of the changing regulatory demands and will guide you through them.
"The experience, knowledge, and power to ensure pharmacovigilance that fits your needs"

The Dokumeds pharmacovigilance team is a group of skilled medical professionals led by Kerstin Fleischer, a drug safety expert. Kerstin has over 20 years of managerial experience in the industry and knows how to build efficient communication lines and set up the right priorities. To find out more about how Dokumeds can help streamline your pharmacovigilance infrastructure, book a quick call today. 


  1. https://www.ema.europa.eu/en/news/how-will-pharmacovigilance-look-2030
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