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    Report Type Focus Key Purpose
    Aggregate Reports Worldwide safety summary over defined intervals. Fulfilling global periodic reporting requirements.
    Development Safety Update Report (DSUR) Clinical Trials (Pre-Approval) Reporting on the safety of investigational products.
    Periodic Benefit-Risk Evaluation Report (PBRER) / PSUR Marketed Products (Post-Approval) Comprehensive assessment of benefit-risk balance.
    Pharmacovigilance System Master File (PSMF) Detailed PV System Description (EU) Mandatory document proving the PV system is compliant with GVP.
    Safety Writing Ad-hoc reports, protocols, and regulatory queries. Providing expert medical/scientific rationale for regulatory bodies.