SDEA

PvMF

QMS

Pharmacovigilance System Master File (PSMF/PvMF)

Maintain pharmacovigilance system master file

Provide QPPV services

 

Safety Data Exchange Agreements

Create Safety Data Exchange Agreement templates

Update and Maintain executed agreements

Perform and document periodic reconciliations

 

QMS (Quality Management System)

Prepare and maintain safety policies and SOPs

Provide relevant training and document through LMS

Implement and manage CAPA systems

 

Pointers for compliance

Author SOPs and safety policy documents
Track training metrics and compliance
In person training sessions
Training through LMS
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Documentation of Safety Agreements
Root cause analysis for incidents