Pega brings together process and decision-based technology to create a flexible, reusable Adverse Event Case Processing and product complaint environment that provides rapid configurability and flexibility to address global requirements. Automated and configurable business rules ensure compliance while simplifying process efficiency.
Life sciences organizations need a better way to manage complex safety activities. Pega pharmacovigilance revolutionizes how you collect, manage, analyze, and distribute safety information in compliance with varying global regulations. Pega PV brings end-to-end visibility and control using case management and real time dashboards to ensure work remains on track. You can easily access all current activities, including cases, sub-cases, assignments, and deadlines.
The dynamic intake module intelligently guides users through the process of collecting required information about the adverse event or product complaint. Pega PV captures information about the case, reporter, subject, and relevant questions and information to support automated case classification. Unlike conventional safety systems, Pega's rules driven interface dynamically changes questionnaires based on specific product information, risk profiles, and regulatory requirements.
Pega PV automates global distribution through reporting rules, and generates multiple submission formats. All of these can be created, viewed, and updated through managed reporting rules directly in the application. The exchange module manages PV agreements and the associated responsibilities of partners for cross-licensed products to help your organization achieve regulatory compliance and improve efficiency by reducing duplicate activities.
Pega PV, built on the Pega 7 platform, can be deployed on premise and in the cloud to maximize your business flexibility. With Pega, life sciences organizations can maintain regulatory compliance, deliver a customer-focused experience, and dramatically improve safety management activities to reduce cost and complexity.