You call it as Pharmacovigilance Software solutions or Pharmacovigilance database or drug safety database, all are used interchangeably. They are also termed as Pharmacovigilance System. You cannot maintain huge amount of Adverse event data in excelsheet. Even if you do, the analysis, quality review and submission of these information in the form of E2BR3 format is very difficult. So it is very much necessary for every Pharmacovigilance department to have a Pharmacovigilance database. Its a costly affair. Some softwares costs in crores, while there are many cheaper options that comes in lakhs. But with cost comes a security of patient safety data. All the softwares or databases mentioned below are validated softwares.
Top Pharmacovigilance Software Solutions
Now that you know what to look for, let’s explore some of the leading pharmacovigilance software solutions available in 2025:
1. Oracle Argus Safety
Overview
Oracle Argus Safety is widely regarded as the gold standard for comprehensive drug safety management. Designed for pharmaceutical companies, biotech firms, and CROs, it integrates seamlessly across case management, regulatory compliance, and risk management.
Key Features
- Auto and force distribution for expedited reporting
- Advanced automation to reduce manual entry
- Integration with signal detection and benefit-risk assessment tools
Why Choose It
Argus ensures global regulatory compliance and is continuously enhanced to meet industry demands. It is particularly valuable for companies that manage high case volumes.
2. ARISg (LifeSphere)
Overview
ARISg by ArisGlobal is another leading pharmacovigilance system, known for its flexibility and advanced automation features.
Key Features
- Automatic generation of submission-ready reports (e.g., CIOMS 1, MedWatch 3500A)
- Robust integration with regulatory authorities and internal systems
- Flexible workflow configurations
Why Choose It
ARISg is an excellent choice for organisations seeking a configurable and integrated pharmacovigilance platform.
3. AB Cube SafetyEasy
Overview
AB Cube offers SafetyEasy as a user-friendly, cloud-based pharmacovigilance platform.
Key Features
- Built-in query and reporting functionalities
- Validation to comply with the latest regulatory standards (e.g., periodic reporting)
- SaaS deployment model for easy updates
Why Choose It
Its intuitive design and rapid deployment model make AB Cube SafetyEasy an ideal choice for smaller teams.
4. Clinevo Safety
Overview
Clinevo Safety is a robust, all-in-one pharmacovigilance database designed to handle a high volume of cases while integrating key AI and analytics features. It is very cost effective in comparison with Argus and Arisg
Key Features
- Case processing with configurable workflows
- AI-driven analytics for predictive insights
- Compliance with global regulations like 21 CFR Part 11, GxP, and GDPR
Why Choose It
Its powerful AI and ability to process over 100,000 cases annually make it ideal for companies requiring high performance at scale.
5. PvNET
Overview
PvNET offers end-to-end solutions for adverse event reporting and regulatory compliance. It is widely praised for its E2B compliance and multilingual support features.
Key Features
- Automated narratives for adverse events
- Validation checks for data accuracy
- Flexible workflows for case triage and processing
Why Choose It
PvNET goes beyond compliance to provide detailed regulatory reports like MedWatch and PSURs.
Other Notable Pharmacovigilance Software Solutions
While the above options are feature-rich and widely adopted, here are some additional solutions worth considering:
- IQVIA Vigilance Platform: The IQVIA Vigilance Platform is a cloud-based drug safety and pharmacovigilance system designed to simplify and improve every stage of the safety lifecycle. It helps organizations manage drug safety more efficiently by automating processes, reducing costs, and improving data quality. The platform provides easy access to safety data, enabling better decision-making and deeper insights. With built-in automation and continuous improvement features, it enhances compliance, flexibility, and overall pharmacovigilance operations.
- Veeva Vault Safety: Veeva Safety is a modern system for managing individual case safety reports (ICSRs), handling the intake, processing, and submission of adverse events for clinical and post-marketed products. It allows sponsors and CROs to manage global and local adverse events for drugs, biologics, vaccines, devices, and combination products in a single platform. With built-in gateway connections and automated reporting rules, it simplifies case submissions to health authorities and partners.
- TCS ADD Safety Database – A next generation AI Platform for Pharmacovigilance transformation.
- ClinTrace – Known for its reliability in ADR reporting and periodic updates.
- Vigilanz Dynamic Monitoring System – Offers real-time analysis with signal detection capabilities.
- PV works – A versatile solution for managing individual and aggregate safety data.
- PV24/7 – Human and veterinary pharmacovigilance solutions
- Tepsivo Safety Database – Simple and affordable solution for complete ICSR management (includes submission portal functionality).
- PVEdge – It is a robust system that offers extensive documentation and analysis of adverse events resulting from the utilization of various pharmaceutical products, including drugs, medical devices, and vaccines.
- Flex Database: Flex Databases Pharmacovigilance is a comprehensive drug safety database that ensures robust and compliant pharmacovigilance activities both within clinical trials and post-approval stage.
Key Features to Look for in Pharmacovigilance Software
Before selecting a pharmacovigilance tool, consider the following key features:
1. Global Regulatory Compliance
Ensure the software meets international regulatory standards, such as FDA (21 CFR Part 11), EMEA, and ICH guidelines, while supporting detailed reporting like CIOMS forms and MedWatch.
2. Automation and Efficiency
The whole world is speaking about automation. But when it comes to implementation, they are still a long way to go. Look for features such as automated case data entry, duplicate detection, and conditions-based processing to streamline workflows.
3. Data Insights and Decision-Making
Robust analytics, dashboards, and text mining capabilities provide actionable insights to help identify safety risks and trends. A beautiful dashboard that gives all the required information without deep diving into the system.
4. Adverse Event (AE) Reporting
Choose software that offers easy case intake and seamless generation of Individual Case Safety Reports (ICSRs) in XML formats, both E2b R2 and E2b R3. Gateway integration should be smooth. There should be option for auto scheduling as well as auto submission of reports to Regulatory Authorities.
5. Safety and Risk Management
For end-to-end safety management, the software should integrate features like risk assessment, safety signal detection, and benefit-risk profiling.
6. Data Privacy and GDPR requirements
Patient safety data is a sensitive information and every developed country have laid guidelines and legislations protecting the safety and well being of patients. So it is very important to have the database GDPR compliant. It should mask sensitive information while transmitting data.
Choosing the Right Pharmacovigilance Software
With so many options available, here are a few considerations to guide your decision:
- Scalability – Can the software grow with your organisation?
- Budget – Does the solution balance features with affordability?
- Ease of Use – Is the user interface intuitive for your team?
- Integration – Can it integrate with your existing systems?
- Compliance – Does it meet industry standards like 21 CFR Part 11 and ICH E2B?
Final Thoughts on Pharmacovigilance Software
If you have good budget, you may go with Argus, Arisg, ABCube, TCS, Veeva, Iqvia databases. If you have a tight budget you can see the rest of the softwares. If you are interested in buying any, kindly connect with us at Pharmacovigilancejob@gmail.com.
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