Tag: safety database automation

The global spontaneous reporting system now spans databases of extraordinary scale. FAERS alone holds 31.8 million records,EudraVigilance contained over 29.3 million ICSRs as of early 2024,and in early 2025, WHO VigiBase crossed 40 million reports. FAERS alone receives over two...

Every six months, or annually depending on the product’s EU reference date (EURD) schedule, pharmacovigilance teams begin assembling one of the most resource-intensive documents in drug safety: the Periodic Benefit-Risk Evaluation Report (PBRER), or its regulatory counterpart, the Periodic Safety...

A pharmacovigilance team managing multiple products globally runs hundreds of literature searches each week. They log adverse event reports from call centers, emails, patient portals, and clinical trial feeds. Every day, cases arrive that require review, coding, triage, narrative writing,...