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Risk Minimization Measures
Communication with Quality Assurance Department
Communication of Safety Concern to Concerned Parties
Safety Data Exchange Agreements
Pharmacovigilance Training
Periodic Safety Update Report
Pharmacovigilance Audits
Signal Detection and Processing
Project management and agreeing responsibilities
Addendum of Clinical Review
DSUR Preparation
Continuous Monitoring of Product Risk-Benefit Profile
ICSR Collection, Collation, Follow-up, Assessment and Reporting
PSUR Scheduling, Production and Submission
PV System Master File (PSMF) Preparation and Maintenance
Regulatory Intelligence
Safety Data Reconciliation
Risk Management Plans
Qualified persons for pharmacovigilance
Documents Handling and Archiving
Handling Communications With Regulatory Authorities
Quality Complaint and MI
Implementation of Safety Variation to the SmPC
This course contains all 23 Pharmacovigilance Standard operation procedures.
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Layal Feghali, Senior Quality Associate at ClinGroup. Responsible for the Quality Management System for units/departments.
