WHY GLOBAL PHARMACOVIGILANCE NEEDS AI | CHAPTER 8The Future of Pharmacovigilance Case Management


Achieving good pharmacovigilance case management is crucial for all life sciences organizations. It assures that companies comply with regulations so they can continue to access desired markets and avoid costly penalties.

It bolsters the manufacturer’s reputation, maintains public trust in a company or product, and upholds perceptions of safety and reliability. It also brings economic benefits, minimizing the expensive impacts of drugs being withdrawn or recalled. Finally, it ensures that patients feel confident their health is being safeguarded and their medicines appropriately monitored.

Despite its undeniable benefits, optimizing pharmacovigilance case processing is a hugely challenging endeavor. However, organizations can now use AI to better manage pharmacovigilance cases across global markets.

Choosing an LSP with the expertise to implement AI solutions effectively can bring faster, more consistent, and more cost-effective case management on a worldwide scale. In fact, AI solutions are increasingly sought after throughout the life sciences industry for many applications, including the automated detection of potential AEs in medical documents and predictive analytics to spot possible safety issues before they become widespread.

Alongside implementing AI solutions, in today’s globalized world, it has become essential to centralize and localize teams and ways of working. Localization assures that output is appropriate for target audiences with diverse linguistic and cultural backgrounds, while centralization guarantees standardized quality, accuracy, and consistency across all markets. This approach can expedite TATs without sacrificing quality, resulting in quicker processing of AE reports to prioritize patient safety.

Patient safety is the ultimate goal of any life sciences manufacturer. AEs1 are reported to be the most common cause of hospital admission and a leading cause of death worldwide, despite most reactions likely being avoidable.2

Good pharmacovigilance can detect and manage AEs early, reducing their prevalence and subsequent public health burden. This can reduce the cost of hospitalization and, most importantly, prevent the risk of harm to patients.

  1. Davies, E, Green, C, Mottram, D, Pirmohamed, M. Adverse drug reactions in hospitals: a narrative review. DOI: 10.2174/157488607779315507
  2. Pirmohamed, M, et. al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. DOI: https://doi.org/10.1136/bmj.329.7456.15