Pharmacovigilance Safety Database

PvEdge pharmacovigilance safety database is a robust system that offers extensive documentation and analysis of adverse events resulting from the utilization of various pharmaceutical products, including drugs, medical devices, and vaccines. PvEdge stands out as an advanced and highly automated Pharmacovigilance Safety Database, simplifying the management of safety data while addressing all risk management needs on a unified platform. This comprehensive approach guarantees compliance with global regulatory standards. It’s time to choose a trusted Pharmacovigilance Safety Database.

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Drug Safety Database

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3 Major Covid vaccines in India has been processed successfully in PvEdge

An Efficient Pharmacovigilance Safety Database

Core ICSR Case Processing Solution

Submission Outputs

R3 & R2, MedWatch, CIOMS, VAERS (Country specific requirements) PvEdge Pharmacovigilance software provides comprehensive submission outputs, including Regulatory Reports R3 and R2, MedWatch reports, CIOMS forms, and VAERS submissions, to meet specific country-specific requirements with precision and efficiency.

Vigilance Coverage

Medicinal Products, Clinical Trials, Veterinary, Combinational Products This Drug safety database also offers robust vigilance capabilities, encompassing medicinal products, clinical trials, veterinary medicines, and combinational products, providing streamlined and efficient monitoring and reporting solutions across diverse sectors.

Data Privacy

GDPR & HIPPA
PvEdge Safety Database ensures rigorous data privacy compliance, seamlessly integrating GDPR (General Data Protection Regulation) and HIPAA (Health Insurance Portability and Accountability Act) standards, safeguarding sensitive information and ensuring regulatory adherence.

Values

Auto-Scheduling, alert management, Follow up & Notice management, case allocation
The Pharmacovigilance safety database software delivers a seamlessly integrated solution, encompassing auto-scheduling, alert management, follow-up and notice management, as well as efficient case allocation, streamlining operational processes and enhancing overall workflow efficiency.

Globally Compliant

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Adheres to existing and upcoming regulations, such as 21 CFR Part 11, ANNEX 11, GxP, and GDPR, and stays current with the latest regulatory revisions.

Comprehensive Safety Database

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Manages PV intake, case processing, submissions, AI & analytics, and safety signals all in one platform.

Advanced Analysis

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Delivers robust insights, primed for informed decision-making.

Advanced Automation

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Utilizes advanced automation in drug safety database management powered by AI and ML algorithms.

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