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Zelthy-Pharmacovigilance & AE Management

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What is this product? Zelthy Pharmacovigilance & AE Management is an application for pharmaceutical drug safety teams managing adverse event operations. It covers the full AE lifecycle: multi-channel intake (calls, emails, field reports, literature), case processing and medical assessment, deadline-driven regulatory reporting, signal detection and trending, and health authority submission formatting — providing a structured workflow for the time-critical requirements of pharmacovigilance. Key Features & Functionalities - Multi-channel adverse event intake (calls, email, social, field, literature) - Case processing with medical assessment workflows - Deadline management for regulatory reporting timelines - Submission formatting per health authority requirements - Signal detection and safety trending analytics Primary Solution & Value Pharmacovigilance is one of the most time-critical and regulated functions in pharma — serious adverse events must be reported to health authorities within strict timelines. Manual case processing and deadline tracking creates risk of missed submissions. This application structures the AE lifecycle from intake through submission, ensuring regulatory timelines are met and emerging safety signals are detected early.

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