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Sanofi PV Resources Toolbox
Sanofi PV Resources Toolbox
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.
Patient Programs
refers to PSP (Patient Support Program), PAP (Patient Assistance Program), and CPP (Combination Patient Program)
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, and Passive Social Media Listening as well as services applying the Sanofi standard of Conduct of Market Research
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.)
“Other activities”
refers to outsourced activities that are different from Patient Programs, Market Research, or Digital Properties
If you are newly assigned to any of the activities above, 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.
Important changes – August 26th, 2024
From Monday 26 August 2024 you will find updated PV Packet documents for use in Patient Programs, Market Research and Digital Properties:
PV Data Reporting forms were added to be used according to the type of activity:
Solicited Individual Safety Information (ISI) Collection & Documentation Form
-> New Document
Unsolicited Individual Safety Information (ISI) Collection & Documentation Form
-> New Document
Reconciliation templates were modified to include the INBOX ID as a possible PV Data report reference
-> New Version
Instructions for Self-Registration and Training Access to iLearn were updated to add User Support contact details
-> New Version
Global Instructions for Completion of the Solicited ISI
-> New Document
Global Instructions for Completion of the Unsolicited ISI
-> New Document
PV Contact List
-> New Version
Please read the updated
Guidance for Reporting of PV Data
and carefully follow the instructions on how to use the forms and the PV Portal
For any questions about the use of the PV Packets, please contact: PSPVGovernance@sanofi.com. Please DO NOT use this email address to report PV data.
For any questions on your contracted activity, please contact the Patient Program or Market Research Project Leader, or the Sanofi Business owner.
Category of Activities
Patient Programs – PV Packet documents
Global Instructions for Completion of the Solicited ISI
Solicited Individual Safety Information (ISI) Collection & Documentation Form V1
Instructions for Self-Registration and Training Access iLearn-PP_MR_DP-V2.0
PTC contact list March 2024
PV Contact List_07-Aug-2024
PV Data Reconciliation and QC checks for Patient Programs_Template and Instructions_V6.0_August_2024
Market Research – PV Packet documents
Global Instructions for Completion of the Solicited ISI
Solicited Individual Safety Information (ISI) Collection & Documentation Form V1
Instructions for Self-Registration and Training Access iLearn-PP_MR_DP-V2.0
PTC contact list March 2024
PV Contact List_07-Aug-2024
PV Data Reconciliation for Market Research_Template and Instructions_V4.0 - August 2024
Digital Properties – PV Packet documents
Decision Tree Algorithm for multi country projects V1
Unsolicited Individual Safety Information (ISI) Collection & Documentation Form V1
Global Instructions for Completion of the Unsolicited ISI
Instructions for Self-Registration and Training Access iLearn-PP_MR_DP-V2.0
PTC contact list March 2024
PV Contact List_07-Aug-2024
PV Data Reconciliation for Digital Properties_Template and Instructions_V4.0_August_2024
Other activities
Unsolicited Individual Safety Information (ISI) Collection & Documentation Form V1
Global Instructions for Completion of the Unsolicited ISI
Instructions for Self-Registration and Training Access- iLearn - General Vendors - V3.0
PTC contact list March 2024
PV Contact List_07-Aug-2024
For any question please reach out to your Sanofi Business Contact, the Program or Project Leader, or your Sanofi manager.
General Information & Important Communications and Guidance
General Information
Important communications and guidance
Guidance on Blood Glucose and HBA1C for diabetes patients (Patient programs and Market Research)
Guidance on Lab data (Patient Programs and Market Research)
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