QPPV.COM KNOWLEDGE ASSESSMENT

PSMF Oversight

Test your understanding of the concepts covered by PSMF Oversight.

Question 1 of 10Pass mark: 80%

Question 1 of 10 An inspector asks how a statement in the PSMF about expedited reporting is supported. Which response demonstrates the strongest traceability?

Provide an informal explanation from a senior PV employee Provide the current controlled SOP, workflow evidence and relevant performance records through a clear cross-reference Provide an obsolete procedure because it shows historical development State that the PSMF itself is sufficient evidence

Question 2 of 10 A QPPV delegates coordination of a PSMF update to the Head of PV. Which control is most important?

No additional control is needed if the Head of PV has worked at the company for more than one year The delegation should be documented, while QPPV or authorised-delegate approval and accountability remain clear The Head of PV should approve the change without QPPV visibility The PSMF should omit the change from its version history because the work was delegated

Question 3 of 10 Which sequence best reflects appropriate change control for a substantive PSMF amendment?

Publish the amendment, then determine its impact if inspectors ask Describe the change, assess impact, obtain SME and quality review, secure QPPV or authorised approval, update version history and archive the prior version Ask the affected vendor to approve the amendment and delete the prior version Update the document informally and wait for the annual review to record it

Question 4 of 10 What is the main purpose of documenting interfaces with Regulatory Affairs, IT, Legal, Clinical and Commercial functions in the PSMF?

To demonstrate how PV responsibilities and dependencies operate across the wider organisation To replace all cross-functional procedures To show that those functions are legally responsible for the entire PV system To limit the PSMF to activities performed by the central safety department

Question 5 of 10 Which statement best explains why archived PSMF versions should be retained?

They are useful only for preparing marketing materials They provide an auditable history of what the PV system description contained and why changes were made They allow obsolete procedures to remain operational They eliminate the need to document current approvals

Question 6 of 10 Why should the PSMF include vendor oversight evidence rather than only a list of vendors?

Because the existence of a vendor proves that the activity is compliant Because inspectors need evidence that the MAH actively supervises outsourced PV activities and manages performance or deficiencies Because vendors are required to approve the PSMF Because a vendor list is not relevant to the PV system

Question 7 of 10 Which KPI would most directly measure the organisation's ability to respond to a remote inspection request?

Number of medicinal products in the portfolio Time taken to assemble the remote inspection pack or provide requested PSMF evidence Number of pages in the organisational chart Percentage of employees with non-PV training

Question 8 of 10 Which information belongs primarily in the organisation and personnel section of the PSMF?

A list of all product marketing authorisation numbers The PV organisation chart, roles, deputies, local PV leads and competence-management approach The complete text of every individual case safety report Only the names of external auditors

Question 9 of 10 Why should patient-identifiable information generally not appear in PSMF annexes?

Because inspectors are not permitted to review any safety information Because PSMF evidence should respect data protection and confidentiality requirements, using appropriate redaction when case excerpts are necessary Because case information is never relevant to pharmacovigilance oversight Because redaction removes the need for data-processing agreements

Question 10 of 10 Which annex would be the most direct source for verifying who may act for the QPPV during an absence?

Annex B on deputies and local PV contacts Annex D on product and marketing authorisation documentation Annex H on training records Annex L on data protection arrangements

PSMF Oversight

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