SafetyEasy PV Human

The Pharmacovigilance Software

The Pharmacovigilance software fully dedicated to the management of Adverse Event related to medicinal products.


E2B R3 fully compliant

SafetyEasy PV Human is already E2B R3 HL7 fully compliant.


Full MedDRA services

Automatic recoding and SMQ


Integrated BI solution

Business Intelligence tool integrated


WorkFlow integrated

A fully customizable workFlow is integrated with SafetyEasy. It can be modified to follow with ease your company organization.


Gateway integrated

Our Gateway is available to exchange with EMA and FDA. SafetyEasy could be used with Web Traders too.

Pharmacovigilance Software

SafetyEasy is more than a Pharmacovigilance E2B R3 database



  • GAMP 5 validation
  • On-line valdation dossier available
  • Validation dossier updated
  • Minimum validation effort

Full services

  • Transparency (Access to online Document Management system)
  • eLearning
  • 24 / 7 hotline
  • Validation software
  • Ticketing software

Secured & Reliable

  • HIPAA compliant
  • SSL web access
  • BackUp & Restore
  • 99,99 % SLA guaranteed
  • 21 CFR part 11 Full Audit Trail
  • ISO 27001 data center (Tiers III plus)

Fast & User Friendly

  • Full web (pure HTML)
  • All web browser compatibility
  • Customization available
  • Easy and fast Data Entry
  • Fully customizable WorkFlow

Fair pricing

  • No hidden costs
  • Clear and adaptative offer (From Basic to Professional)
  • Unlimited number of users

SaaS & On-Premise

  • Hosted solutions
  • On-Premise solution
  • Great experience in data migration

Scalable & Flexible

  • Full Query module integrate
  • Totally customizable by end users
  • Fully customizable Work Flow
Pharmacovigilance software’s Key Features
  • User friendly Data Entry
  • E2B R2/R3 Data entry
  • MedDRA codder
  • Check duplicate management
  • E2B validation
  • Attach document
  • Narrative template generation
  • Follow Up Management


  • MedDRA SMQ
  • IME management
  • Query module intergated
  • Calendar (Submission & Follow-up management)
  • Automatic Mail generation
  • Task Scheduler (Change MedDRA version for exemple)
  • CIOMS I, MedWatch, …
  • XML E2B R2/R3 HL7 Import / Export
  • Line-Listing (PSUR, PBRER, DSUR, …)
  • Summary tabulation (PSUR, PBRER, DSUR, …)
  • Signal detection : PPR, Qualitative
  • Full Work Flow management
  • XEVMPD IMPD dictionaries management
  • Reportability matrix management
  • Users administration
  • User’s group rights management
  • EudraCT import
  • AB Cube’s Gateway or Web Trader integration
  • Link with SafetyEasy MI
  • WHO Drug Dictionnary integration
  • XEVMPD / IDMP integration
  • EudraCT link

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