Whenever a patient takes a drug and has an unexpected side effect — from minor problems like a runny nose to more serious ones that require hospitalization — pharma companies are legally required to report this information, known as an adverse event (AE), to regulatory agencies.
Within the pharmaceutical industry, AE reporting is a critical and time-consuming part of ensuring the safe and effective use of medicines by patients. Pharmacovigilance employees process a growing number of cases from sources as varied as patients’ social media accounts to reports from investigators overseeing clinical trials. Pfizer’s Worldwide Safety organization processed approximately 1.4 million AEs globally in 2019 alone. Looking forward across the industry, the volume of AEs is expected to increase by 20% annually.