Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: Dr. Priya Verma, Mr. Arjun Rao

ABSTRACT: Signal detection and assessment are core components of pharmacovigilance, enabling timely identification of potential adverse drug reactions (ADRs) and drug safety issues. With the increasing complexity of pharmaceuticals and the scale of patient exposure, advanced methods for signal identification have become crucial. This paper reviews methodologies employed in signal detection, including spontaneous reporting systems, data mining, electronic health records, and statistical algorithms. Signal assessment techniques are discussed, emphasizing causality evaluation, prioritization, and risk mitigation. Comparative perspectives from global pharmacovigilance practices are presented, highlighting best practices and challenges. Tables summarizing key methodologies and tools provide practical insights for professionals. Integrating technology, enhancing reporting culture, and standardizing assessment protocols are highlighted as essential strategies for improving pharmacovigilance outcomes.

KEYWORDS: Signal Detection, Pharmacovigilance, Adverse Drug Reactions, Data Mining, Risk Assessment, Drug Safety