Pharmacovigilance and Drug Safety Software Market Size, Share, Growth Analysis, By Functionality (Adverse Event Reporting Software, Drug Safety Audits Software), By Deployment Mode (On Premise, Cloud), By End User (Pharma and Biotech Companies, BPO), By Region - Industry Forecast 2025-2032

Pharmacovigilance and Drug Safety Software Market size was valued at USD 194.33 Million in 2023 and is poised to grow from USD 214.73 Million in 2024 to USD 358.06 Million by 2032, growing at a CAGR of 10.5% during the forecast period (2025-2032).

The global pharmacovigilance and drug safety software refers to specialized computer programs designed to improve tracking, analysis, checks and reports related to Adverse Drug Reactions (ADRs) and other drug safety issues. In Romania on its part, software programs for pharmacovigilance are crucial in ensuring safe and efficient use of medicines by monitoring their effectiveness and side effects. These software tools can facilitate collection, management and analysis of big data on drug safety by pharmaceutical companies, regulatory agencies and healthcare professionals. Moreover, they can identify potential risks and trends which enable timely interventions and risk minimization strategies.

Primary users of the PV software include large pharmacovigilance solution providers, BPOs, and contract research organizations (CROs). The market's future is being shaped by many forces, possibilities, and constraints. The global pharmacovigilance and drug safety software market has been driven by several significant factors, one of which is the rising prevalence of adverse drug reactions. Additionally, the market's future has been brightened by the growing rate at which outsourcing organizations are adopting this kind of software. However, the FDA, EMEA, and other government agencies have stepped up their pressure on biotechnology and pharmaceutical companies to produce safe medications. Additionally contributing to the industry's growing market share is the previously mentioned factor.