We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.
PV Risk Manager
PV Risk Manager -One Simplified Platform for Proactive RMP, GVP Module V, and REMS Oversight
PV Risk Manager is a robust, end-to-end risk management solution that centralizes the creation, tracking, and governance of Risk Management Plans (RMPs), fully aligned with GVP Module V and FDA REMS requirements.
Powered by AI-driven intelligence and natively integrated with the award-winning PV Signal and PV Reports platforms, PV Risk Manager connects signals, actions, and outcomes into a single, governed workflow, enabling proactive risk oversight, consistent execution, and inspection-ready compliance across the product lifecycle.
This is not an add-on.
It is a first-of-its-kind, unified risk management capability, delivering simplified operations, stronger benefit–risk decisions, and end-to-end safety governance at scale.
Unified Risk Oversight: Get a holistic view of product safety profiles and proactively manage identified and potential risks.
Intelligent RMP Authoring: Create and manage Risk Management Plans with configurable templates and automated population.
AI-Powered Workflow Automation: Streamline authoring, review, and updates with version control and real-time progress alerts.
Seamless Integrations: Connect with document management systems and safety reference repositories effortlessly.
Submission-Ready Outputs: Generate finalized RMP content for inclusion in aggregate reports with user-defined checklists
Smart Search & Task Management Quickly sort, search, and manage tasks with user-based to-do lists for risk categories.
Flexible User-Friendly Interface : Provides flexibility to have standard and configured fields to enter and maintain the product safety summary/planning/safety strategy, safety risk and commitments information.
End to end RMP/REMS Management : Provides a user-friendly IT System environment to author, review and approve the RMP/REMS. No need to manage the contents in MS Word and SharePoint systems.
Product Profile : Provides an integrated safety profile of the drug where all relevant information is available at one place.
Automated Emails Alerts and Notifications : Provides ability to receive email alerts and online notifications, no need to actively monitor to-do lists.
Reporting and Metrics : Provides standard reporting capability on all the available Risk Management data.
Role-based centralized work environment for Safety Scientists and Physicians : Provides integrated and centralized environment linking all Risk Management-Signal Management-Aggregate Reporting-Data Analysis activities.
Workflow and To-Do Lists : Provides a very user-friendly way to configure and manage workflow for RMPs, Safety Strategy Plans, and Safety Topics and the associated user and/or role-based to-do lists, internal and external commitments.
GxP and 21 CFR Part 11 Compliance : Provides full compliance with GxP and 21 CFR Part 11 requirements.
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.
