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
Document Title Version Effective Date
Guidance for Reporting of PV Data V1.0 26 August 2024
NEW Global Instructions for Completion of the Solicited ISI V2.0 10 June 2025
Solicited Individual Safety Information (ISI) Collection & Documentation Form V1.0 26 August 2024
Instructions for Self-Registration and Training Access iLearn - PP_MR_DP V3.0 24 April 2025
PTC contact list - March 2024
PV Contact List - 10 Feb 2025
PV Data Reconciliation and QC checks for Patient Programs_Template and Instructions V6.0 August 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
Document Title Version Effective Date
Guidance for Reporting of PV Data V1.0 26 August 2024
NEWGlobal Instructions for Completion of the Solicited ISI V2.0 10 June 2025
Solicited Individual Safety Information (ISI) Collection & Documentation Form V1.0 26 August 2024
Instructions for Self-Registration and Training Access iLearn-PP_MR_DP V3.0 24 April 2025
PTC contact list - March 2024
PV Contact List - 10 Feb 2025
PV Data Reconciliation for Market Research_Template and Instructions V4.0 August 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.
Document Title Version Effective Date
Guidance for Reporting of PV Data V1.0 26 August 2024
Decision Tree Algorithm for multi country projects V1.0 -
Unsolicited Individual Safety Information (ISI) Collection & Documentation Form V1.0 26 August 2024
NEWGlobal Instructions for Completion of the Unsolicited ISI V2.0 10 June 2025
Instructions for Self-Registration and Training Access iLearn-PP_MR_DP V3.0 24 April 2025
PTC contact list - March 2024
PV Contact List - 10 Feb 2025
PV Data Reconciliation for Digital Properties_Template and Instructions V4.0 August 2024

Other Activities refers to

  • Outsourced activities through which PV data can be reported that are different from Patient Programs, Market Research or Digital Properties
Document Title Version Effective Date
Guidance for Reporting of PV Data V1.0 26 August 2024
Unsolicited Individual Safety Information (ISI) Collection & Documentation Form V1.0 26 August 2024
NEW Global Instructions for Completion of the Unsolicited ISI V2.0 10 June 2025
Instructions for Self-Registration and Training Access iLearn - PP_MR_DP V3.0 24 April 2025
PTC contact list - March 2024
PV Contact List - 10 Feb 2025

General Information

Date of page update Updates
June 20th, 2025
  • Global Instructions for Completion of the Solicited ISI
  • Global Instructions for Completion of the Unsolicited ISI
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
August 26th, 2024
  • Several documents updated to align with new PV Data reporting tools
  • Guidance for Reporting of PV Data: carefully follow the instructions on how to use the forms and the PV Portal