Vendor Oversight for QPPVs

Store documents in separate locations with inconsistent naming and no cross-references. Maintain an indexed inspection repository with links from dashboard metrics and PSMF references to source evidence. Rely on individual employees to recall where documents are stored. Retain only final summaries and discard source records.

A vendor supplying office furniture to the PV department. A vendor providing safety database hosting for regulatory case submissions. A vendor providing non-PV translation services for internal newsletters. A vendor supplying general travel management services.

An annual vendor satisfaction survey with no escalation criteria. Documented incident criteria, defined escalation pathways and records showing timely notification and response. A contract stored in an inaccessible archive. A dashboard that displays only monthly workload volume.

Review each KPI in isolation and close the dashboard after noting its colour. Combine KPI trends, audit findings, CAPAs, incidents and dependency risks to drive documented preventive and corrective decisions. Use only vendor-reported metrics and avoid independent verification. Focus exclusively on achieving contractual throughput targets.

To negotiate every commercial term personally. To understand which responsibilities are allocated, shared or retained and how the arrangements support accountability. To treat the SDEA as a substitute for the PSMF. To review only the vendor's payment and termination provisions.

The vendor has necessarily improved its controls. The issue is purely a contracting matter with no PV governance relevance. There may be broader weaknesses in governance, root-cause analysis or control effectiveness. CAPAs should be closed automatically when their due dates expire.

They demonstrate how data and responsibilities move across the PV system and help identify control gaps. They eliminate the need for SDEAs and contracts. They are primarily financial documents used to calculate vendor fees. They allow responsibility to be assigned exclusively to the vendor.

The provider assumes the MAH's pharmacovigilance accountability. The QPPV is no longer required to understand the case-processing process. The activity may be delegated, but the MAH and its QPPV retain accountability for effective oversight. The activity becomes outside the scope of the PSMF.

Daily work queues, staff attendance and invoice totals only. Significant incidents, audit follow-up, CAPA effectiveness and unresolved escalations. Vendor marketing materials and general customer satisfaction scores. The full text of every contract and every operational email.

Does the vendor have the lowest contract price? Does the vendor have the largest number of employees? If the vendor failed tomorrow, would pharmacovigilance compliance be affected? Has the vendor been operating for more than five years?