Welcome to the Sanofi PV Resources Toolbox


This is your one-stop shop for pharmacovigilance (PV) information and documents related to the PV requirements applicable to the Sanofi activity you are working on.


If you are newly assigned to any of the activities below, you need to complete the corresponding PV training before engaging in the activity. Please refer to the iLearn instructions in the category applicable to your activity and follow all the steps.


Please find the history of this page updates in the What's New section.




Category of Activities and PV packets

Patient Programs refers to

  • PSP - Patient Support Program
  • PAP - Patient Assistance Program
  • CPP - Combination Patient Program

Training slides are provided for reference. Training is considered taken only when successfully completed in iLearn

Document Title Version Effective Date
NEW Guidance for Reporting of PV Data V2.0 09 March 2026
NEW Global Instructions for Completion of the Solicited ISI Form V3.0 09 March 2026
NEW Solicited Individual Safety Information (ISI) Collection & Documentation Form V2.0 09 March 2026
NEW Instructions for Self-Registration and Training Access iLearn V4.0 March 2026
NEW PV Data Reconciliation and QC checks for Patient Programs_Template and Instructions V7.0 09 March 2026
NEW PTC Contact List - February 2026
NEW PV Contact List - 09 March 2026
NEW PV and PTC Requirements for Patient Programs V9.0 October 2024

Market Research refers to

  • Customized Primary Market Research (PMR)
  • Customized Syndicated PMR
  • Active Social Media Listening (Prospective analysis)
  • Syndicated Secondary Market Research (SMR)
  • Non-Customized Syndicated PMR
  • Passive Social Media Listening as well as services applying the Sanofi standard of Conduct of Market Research

Training slides are provided for reference. Training is considered taken only when successfully completed in iLearn

Document Title Version Effective Date
NEW Guidance for Reporting of PV Data V2.0 09 March 2026
NEW Global Instructions for Completion of the Solicited ISI Form V3.0 09 March 2026
NEW Solicited Individual Safety Information (ISI) Collection & Documentation Form V2.0 09 March 2026
NEW Instructions for Self-Registration and Training Access iLearn V4.0 March 2026
NEW PV Data Reconciliation for Market Research_Template and Instructions V5.0 09 March 2026
NEW PTC Contact List - February 2026
NEW PV Contact List - 09 March 2026
NEW PV and PTC Requirements for Market Research V8.0 October 2024

Digital Properties refers to

  • The monitoring of websites, web pages, blogs, social media, networks, channels, internet fora, chat rooms, health portals and mobile applications collecting information
  • Active Social Media Listening, eCommerce platforms, sponsorship to third party (social influence campaigns, congresses, medical education, etc.

Training slides are provided for reference. Training is considered taken only when successfully completed in iLearn

Document Title Version Effective Date
NEW Guidance for Reporting of PV Data V2.0 09 March 2026
Decision Tree Algorithm for multi country projects V1.0 -
NEW Global Instructions for Completion of the Spontaneous ISI Form V3.0 09 March 2026
NEW Spontaneous Individual Safety Information (ISI) Collection & Documentation Form V2.0 09 March 2026
NEW Instructions for Self-Registration and Training Access iLearn V4.0 March 2026
NEW PV Data Reconciliation for Digital Properties_Template and Instructions V5.0 09 March 2026
NEW PTC Contact List - February 2026
NEW PV Contact List - 09 March 2026
NEW PV and PTC Requirements for Digital Properties V6.0 October 2024

General Services refers to

  • Outsourced activities through which PV data can be reported that are different from Patient Programs, Market Research or Digital Properties

Training slides are provided for reference. Training is considered taken only when successfully completed in iLearn

Document Title Version Effective Date
NEW Guidance for Reporting of PV Data V2.0 09 March 2026
NEW Global Instructions for Completion of the Spontaneous ISI Form V3.0 09 March 2026
NEW Spontaneous Individual Safety Information (ISI) Collection & Documentation Form V2.0 09 March 2026
NEW PV Data Reconciliation for General Services_Template and Instructions V1.0 09 March 2026
NEW Instructions for Self-Registration and Training Access iLearn V5.0 09 March 2026
NEW PTC Contact List - February 2026
NEW PV Contact List - 09 March 2026
NEW PV and PTC Requirements for General Services V3.0 March 2026

General Information

Date of page update Updates
March 09th, 2026
  • PV packets updated to align with the upgrade of the company Safety Database and the updates of the PV Data reporting tools.
  • “Other Activities” renamed “General Services”, its associated PV Packet aligns with the updated PV process (new PV Clause effective March 9, 2026)
November 6th, 2025
  • Global Instructions for Completion of the Solicited ISI
  • Global Instructions for Completion of the Unsolicited ISI

Note:"administrative changes, no impact on reporting process"

April 24th, 2025
  • Instructions for Self-Registration and Training Access iLearn – new version with updated links to iLearn
February 18th, 2025
  • PV Contact List – updated