Enabling the FDA’s Modernized Safety System

The new FDA FAERS II safety system uses LifeSphere MultiVigilance to advance efficiency and quality with automated AER intake and processing.

A Better and Modern FAERS Built with ArisGlobal

To build a better adverse event reporting system, the FDA replaced part of its pharmacovigilance system with LifeSphere MultiVigilance. 

LifeSphere MultiVigilance delivers the assured compliance, configurability, and flexibility needed to meet the Agency’s growing responsibility for protecting public health and safety.

The Next-Generation Safety System of the FDA and Other Leading Regulators

Built with the Industry, for the Industry

For over 30 years, ArisGlobal has partnered with leading pharmaceutical companies and regulatory agencies to identify innovative ways to solve pharmacovigilance challenges.  

LifeSphere MultiVigilance is the result of close coordination with top global life sciences organizations. Together with our partners, we’ve collaborated on a “best practice” out-of-the-box configuration, developed, tested and refined in real-world settings.


Delivering Real Results to a Global Client Base



Global Colaboration

80% of the top 50 pharma companies are our clients



Efficiency Gains

80% potential efficiency gains driven by our Nava cognitive computing engine



Cost Savings

30% immediate cost savings potential via our advanced automation capabilities




100% compliance with all present and upcoming regulatory standards

Artificial Intelligence and Robotic Process Automation at Work

LifeSphere MultiVigilance is the next-generation safety system from ArisGlobal. It combines artificial intelligence (AI) with robotic process automation (RPA) to help organizations streamline case processing and medical review, substantially reducing manual effort.  

This new platform is transformative for the FDA in its ability to automate key processes, incorporate the latest safety data standards and improve productivity, allowing reviewers to focus on public health and patient safety.

This transformational work will fundamentally improve health outcomes and positively impact mission performance.”

Sean Chaffee

Booz Allen Hamilton, FAERS Program Lead

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