Pega Pharmacovigilance

 Improve speed, compliance and risk management for drug and device safety with
Pega Pharmacovigilance


Provide more accurate information and faster reports to health authorities with less manual effort. Dynamic, multi-channel processes automatically adapt to varying product profiles and reporting rules.


Pega gives you a single point for entry, assessment, and reporting across clinical, contact center, social, and other sources. Easily integrate affiliates, partners, signal, and risk management.


Future-proof your safety operations with rapid configurability. Pega includes automated assessment based on risk profile, and integrates with natural language processing and emerging technologies.

Dynamic Intake

Pega features responsive, multi-channel intake that automatically adapts to products, regions, and risk profiles. The result: Faster intake and higher quality data, for fewer follow-ups. Manage all AEs and Complaints, for any product or source, with clinical, social, and contact center support.

Automated Processes

Accelerate and scale individual and bulk AE case processing with risk-profile-driven assessments and MedDRA coding. Manage affiliate workflows and global submissions, generate MedWatch, CIOMS, E2B M2/R3, and eMDR reports, and ensure data quality with built-in Part 11 audit trails and validations.

Expanded Visibility

Gain transparency and automation for your entire safety ecosystem. With Pega you can connect social media channels and integrate Natural Language Processing and Optical Character Recognition into your processes. Track partner activities, including PV Agreements and cases exchange with partners.

Wrap and Renew

Pega leverages your existing investments, helping you improve the efficiency of your AE intake and work seamlessly with your existing safety system. Readily support and easily extend the latest E2B submission formats, and provide full transparency with automated case status tracking for electronic submissions.

Pharma and Med Device Support

Harmonize and align operations across product types with support for AEs and product complaints for drugs, vaccines, biologics, and med devices. Automate submissions processes for E2B, eMDR, MedWatch, and CIOMS. Tailored interfaces for different product types make case processing more efficient.

Additional Product Features

Move beyond a transactional, data-centric view of patients and healthcare professionals.
Quickly configure business applications with built-in business process and case management.
Create a virtualized application data layer with unique data management capabilities.
Pega’s scaled, tiered cloud environment supports the Pega Customer Service application.
Accelerate the delivery of life sciences applications using the Pega platform
ECM Taxonomy Terms: 
Life Sciences