Improvement Opportunities in Aggregate Reporting Process by Applying DataOps and AIOps Framework

Rajashekhar Jayasheela, Udit Mathur, Md Tauseef Raza

Abstract: The world of pharmacovigilance is at a pivotal turning point, with aggregate reporting no longer being a back-office compliance task but an essential driver of patient safety and regulatory precision. This article provides a layered exploration of how modern pharmacovigilance is evolving through intelligent integration of AI, automation, and data science. It is evident that emerging technologies-particularly when anchored by robust DataOps and AIOps frameworks-are not just streamlining reporting processes but fundamentally reshaping them. Companies are moving beyond manual, time-intensive systems toward agile platforms that support real-time analytics, predictive modeling, and tailored reporting across diverse regulatory landscapes. That said, adopting these innovations is not without challenges: data silos, legacy system integration, and regulatory variability remain persistent hurdles. Still, the narrative here is optimistic-through scalable infrastructure, process standardization, and intelligent automation, pharmaceutical organizations can now drive meaningful reductions in manual workload, improve accuracy, and achieve audit-readiness with consistency. The detailed case examples suggest that when operational frameworks align with cutting-edge technologies, they unlock measurable gains in speed, transparency, and compliance. Ultimately, this signals a shift toward a more proactive, resilient, and insight-driven pharmacovigilance future-one where patient safety is not just preserved but elevated through digital precision.

Keywords: pharmacovigilance automation, aggregate reporting, DataOps and AIOps, AI in safety monitoring, regulatory compliance