Knowledge Assessment: PSMF Vendor and SDEA Management

Effective oversight because the vendor’s contract exists A gap in active performance monitoring and evidence-based oversight That late transmission is acceptable if cases are eventually received That the issue can be handled solely by procurement

To replace all commercial and procurement terms To provide the PV-specific interface defining safety information exchange and responsibilities To transfer MAH accountability to the vendor To authorize the vendor to change regulatory reporting timelines unilaterally

Business continuity, disaster recovery, recovery objectives and failover arrangements Vendor branding and trading name Commercial dispute venue only The frequency of office social events

They prove that the vendor was paid for each case They establish that information was transmitted and received and support reconciliation and auditability They replace the need for follow-up procedures They are needed only for non-safety commercial documents

Reviewing the vendor only when the contract expires Maintaining current inventory data, monitoring KPIs, holding governance reviews, tracking CAPAs and reassessing changes Delegating all oversight to the vendor after onboarding Conducting an audit once and permanently closing the oversight record

A courier transporting office furniture with no PV-related interaction A supplier of general stationery A call-centre receiving adverse event information from patients A landlord providing office premises

Which party assesses seriousness, expectedness and causality and which party performs final submission Which party selects the office catering supplier Which party owns the vendor’s corporate logo Which party determines the competent authority’s legal powers

Include it automatically as a critical PV vendor Exclude it without recording any rationale Document the rationale for exclusion based on its lack of PV interaction Include it only if it has an active SDEA

The discrepancy is immaterial because both documents concern the same vendor The discrepancy indicates a control and document-alignment problem requiring investigation and correction The PSMF always overrides the SDEA automatically The SDEA can be ignored if the vendor usually performs faster

Remove all identifiers and timestamps, including information needed to demonstrate the audit trail Provide appropriately redacted cases while preserving critical metadata such as timestamps and relevant internal case identifiers Provide only blank templates because real cases are never useful Provide unredacted cases regardless of privacy requirements