Pharmacovigilance Governance Knowledge Assessment

Relying solely on the signed PV agreement Combining qualification, KPI review, audits, CAPA tracking, data-access testing and an exit plan Reviewing only the vendor's pricing and staffing levels Allowing the vendor to define and approve its own performance thresholds without sponsor review

Open access for all employees to maximise transparency Validation, role-based access, change control, audit trails and reconciliation procedures Manual deletion of duplicate records without an audit trail Restricting system review to the vendor that operates the database

It provides a basis for correcting systemic contributors rather than repeatedly treating individual symptoms It allows the organisation to avoid documenting incidents It transfers accountability from management to the investigator It is used only for vendor incidents

Only an annual governance meeting Operational meetings as needed, monthly operational review, quarterly governance reporting and annual strategic review Daily board meetings for every safety issue A single meeting held only after a compliance failure

Median time to case entry Percentage of cases meeting expedited reporting timelines PBRER or PSUR submission readiness index Daily number of cases received

The PSMF is unrelated to governance because it contains only technical case data The PSMF should accurately reflect PV organisational arrangements and be controlled, current and rapidly available The PSMF can be updated only after an inspection The PSMF replaces committee minutes and decision logs

A plan that addresses the visible symptom without investigating its cause A time-bound plan with owners, milestones, verification metrics and independent effectiveness assessment where appropriate Closure as soon as the initial corrective action is implemented A verbal agreement that the issue will not recur

The QPPV can always stop distribution without regard to local legal authority The QPPV may act where authorised, while required internal approvals and local legal constraints must be reflected in the authority matrix Only the board can initiate any safety hold A safety hold should wait until the next scheduled committee meeting

Management reporting is primarily a record of historical performance with no operational consequence It should enable senior management to understand risk, make resource decisions and support remediation based on reliable trends and thresholds It should present only favourable KPIs to protect the organisation's reputation It replaces direct QPPV access to senior management

The change may create a mismatch between actual responsibilities and controlled records, weakening accountability and inspection readiness Only the vendor's commercial contract is affected The QPPV no longer needs to oversee the outsourced activities The change is acceptable if employees understand it informally