Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite

  • Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite 1
  • Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite 2
  • Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite 3
Product Description

AI-enabled, cloud-ready,360 pharmacovigilance solution for safety database management. An end-to-end globally compliant safety software for Drugs, Devices, Vaccines and Combinational products from case intake to submissions and reporting.

  • Case Intake
  • Case Processing
  • Case Submission
  • Risk Management Plans
  • Signal Detection
  • CDMS
  • CAPA
  • Document Control and Issuance
  • Training Management


Automations: Triaging | Data Mining | Reporting

Case Intake
Collects data from the literature, regulatory, MICC, Licensing Partner, Clinical Trial and Web Portals

Case Processing
Automates MedDRA updates, patient narratives, causality assessment, XML validation and quality checks

Regulatory Submission
Supports global formats (R2/R3 XML, CIOMS, MedWatch) with a secure AS2 gateway for FDA, MHRA, PMDA, TGA, KFDA, Health Canada, EMA and others.

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Sarjen Systems Private Limited

  • Country/Region:
    India
  • On CPHI since:
    2019
  • Certificates:
    1
  • Employees:
    250 - 499
Company types
Consultancy
IT/Software solution provider
Primary activities
Clinical Research
Contract Research Organisation
Other
Regulatory Affairs
Technology
View company profile
Categories
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Specifications
  • Details
    500K+ cases migrated, 5 Mn+ case processed, 3500+ Users, 100+ Successful Audits, 250+ MAH’s Served
  • Model
    Pre-Validated, Cloud Ready, Globally Compliant, Implementation under 2 weeks, Data Migration Expertise
  • Supplied from
    India
More specifications Fewer specifications
Sales Markets
Show more Show less

Sarjen Systems Private Limited

  • Country/Region:
    India
  • On CPHI since:
    2019
  • Certificates:
    1
  • Employees:
    250 - 499
Company types
Consultancy
IT/Software solution provider
Primary activities
Clinical Research
Contract Research Organisation
Other
Regulatory Affairs
Technology
View company profile

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Sarjen Systems Private Limited resources (2)

  • PV Literature Automation Software to ease your daily activities

    News PV Literature Automation Software to ease your daily activities

    PvEdge PvXtract stands as a next-generation AI-powered solution designed to streamline and accelerate your literature screening process. Built with deep domain intelligence, PvXtract automates manual review tasks, ensuring faster, more accurate identification of safety information from a wide range of global literature sources.

    With advanced Natural Language Processing (NLP) and Machine Learning capabilities, PvXtract intelligently extracts relevant case information, classifies data, and filters out non-relevant articles—saving valuable time for safety professionals.

    Key Highlights:

    AI-driven screening and extraction for high precision and recall

    Automatic de-duplication and smart filtering of irrelevant results

    Seamless integration with your existing PvEdge or third-party safety databases

    Configurable workflows aligning with global regulatory compliance requirements

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    30 Oct 2025
  • Sarjen Profile

    Brochure Sarjen Profile

    A Trusted Partner for Digital Transformation & Automation