Press release
United States Pharmacovigilance Software Market Size & Growth Forecast 2025-2032: AI-Driven Drug Safety | Major Companies likes - Ennov Solutions Inc., Oracle Corporation, ArisGlobal LLC
Pharmacovigilance Software Market
The Pharmacovigilance and Drug Safety Software Market, as examined by DataM Intelligence, provides a thorough industry overview enriched with detailed insights, historical data, and essential statistics. The report extensively explores market dynamics and competitive landscapes, featuring profiles of leading companies, their product offerings, pricing strategies, financials, growth plans, and geographic footprint.
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Pharmacovigilance and Drug Safety Software helps pharmaceutical companies and regulatory bodies monitor, detect, and manage adverse drug reactions, ensuring patient safety, regulatory compliance, and efficient risk management throughout the drug lifecycle.
Prominent Industry players in the Pharmacovigilance and Drug Safety Software Market
The prominent players in Pharmacovigilance and Drug Safety Software Market research report are: Ennov Solutions Inc., Oracle Corporation, ArisGlobal LLC, EXTEDO, Clinevo Technologies, IQVIA, AB Cube, ICON Plc, Paraxel International Corporation.
The companies are primarily focusing on strategies such as new product launches to penetrate the fastest-growing emerging markets across the world.
Industry News
United States - Recent Developments
✅ In July 2025 - Safety software vendors advanced AI-driven tools for duplicate adverse event detection and medical coding, improving automation in pharmacovigilance workflows.
✅ In August 2025 - Cloud-based platforms for drug safety expanded, with companies integrating structured and unstructured safety data into centralized data lakes to strengthen regulatory reporting.
✅ In September 2025 - U.S. regulators and industry stakeholders emphasized the use of real-world data and patient-reported outcomes in safety monitoring, accelerating the shift toward next-generation pharmacovigilance systems.
Japan - Recent Developments
✅ In July 2025 - The PMDA updated its eCTD guidance, tightening validation requirements and metadata structures for pharmacovigilance submissions.
✅ In August 2025 - Major drug safety seminars highlighted the adoption of real-world evidence in safety labeling changes, reinforcing Japan's commitment to data-driven pharmacovigilance.
✅ In September 2025 - Japanese regulators aligned more closely with ICH guidelines, encouraging risk-proportionate oversight and integration of AI tools into safety workflows.
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Market Segments
➥ By Mode of Delivery: On-Premise, Cloud-based, Others
➥ By Functionality: Issue Tracking Software, Drug Safety Audit Software, Adverse Event Reporting Software, Others
➥ By End User: Contract Research Organisations (CROs), Biotechnological Companies, Healthcare Providers, Others
The Pharmacovigilance and Drug Safety Software Market industry is undergoing swift expansion, fueled by breakthroughs in medical technology, growing demand for cutting-edge therapies, and an increasing emphasis on patient-centric care. As the sector advances, in-depth market analysis is essential to track evolving trends, regulatory developments, and new opportunities.
Regions Covered:
The global Pharmacovigilance and Drug Safety Software Market report focuses on six major regions: North America, South America, Europe, Asia Pacific, the Middle East, and Africa.
☞ North America - US, Canada, Mexico
☞ Europe- Germany, Russia, UK, France, Italy, Rest of Europe
☞ Asia Pacific- China, India, Japan, Australia, Rest of Asia Pacific
☞ South America- Brazil, Argentina, Colombia, Rest of South America
☞ Middle East and Africa- Saudi Arabia, UAE, Oman, Bahrain, Qatar, Kuwait, Israel
FAQs:
✒ What is driving the growth of the Pharmacovigilance and Drug Safety Software Market?
✒ Who are the prominent players in the Pharmacovigilance and Drug Safety Software Market?
✒ How is the regulatory landscape affecting the Pharmacovigilance and Drug Safety Software Market?
✒ What regions are expected to see the highest growth?
✒ What are the key challenges faced by the Pharmacovigilance and Drug Safety Software Market?
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