QPPV.COM KNOWLEDGE ASSESSMENT

EU QPPV Requirements Knowledge Assessment

Test your understanding of the concepts covered by EU QPPV Requirements.

Question 1 of 10Pass mark: 80%

Question 1 of 10 A company appoints a technically experienced pharmacovigilance manager as QPPV but gives the role no access to senior management or quality governance. What is the primary regulatory concern?

The QPPV may not have sufficient organisational authority to influence decisions and fulfil the role effectively The QPPV is automatically disqualified because QPPVs must be members of the board The QPPV cannot perform the role unless located in the same country as the MAH headquarters The QPPV may perform only non-serious case processing until access is granted

Question 2 of 10 Which item is most relevant to demonstrating that an electronic safety system supports a controlled pharmacovigilance process?

A system description together with validation evidence and appropriate access records A screenshot of the system homepage with no version or validation information A vendor's marketing presentation An employee's personal spreadsheet listing selected cases

Question 3 of 10 Which activity most clearly falls within the QPPV's system-level oversight responsibilities rather than being limited to case processing?

Entering the patient's date of birth into the safety database Checking whether a single case contains a valid reporter telephone number Reviewing trends in vendor deviations and ensuring effective CAPA implementation Transcribing a product batch number from a source document

Question 4 of 10 Which finding would most strongly suggest that the QPPV's oversight of outsourced activities is insufficient?

A vendor has a signed PVA, current KPIs, documented reviews and completed follow-up actions The PSMF identifies the vendor and links its work to relevant procedures The MAH has no signed PVA, no performance metrics and no evidence of vendor qualification or follow-up The vendor participates in a risk-based audit programme

Question 5 of 10 Which feature is most important when selecting and empowering a QPPV deputy?

The deputy has a senior job title but no access to safety systems The deputy is authorised, trained, recorded in the delegation log and able to execute high-priority PV processes The deputy is familiar only with administrative meeting arrangements The deputy is selected informally whenever the QPPV takes annual leave

Question 6 of 10 An MAH outsources spontaneous case processing to a vendor. Which statement is most accurate?

The vendor assumes the MAH's legal pharmacovigilance responsibility once the contract is signed Delegation may transfer operational tasks, but the MAH and QPPV retain ultimate accountability and must control the delegated activity The QPPV no longer needs access to vendor performance data A purchase order is sufficient; a pharmacovigilance agreement is not needed

Question 7 of 10 An MAH has listed a deputy in an internal email but not in its delegation log or PSMF. What weakness does this most directly indicate?

The deputy cannot legally perform any PV task under any circumstances The availability arrangement is not adequately formalised or inspection-demonstrable The MAH must replace the QPPV with the deputy The PSMF is unnecessary when a deputy is appointed

Question 8 of 10 What is the best interpretation of the requirement for continuous and permanent QPPV availability?

The QPPV must personally answer every communication at any time of day The MAH must have demonstrable arrangements that enable timely response during normal and out-of-hours periods, including absences The QPPV only needs to be reachable during scheduled inspections An automatic out-of-office message is sufficient evidence of availability

Question 9 of 10 Which provision is most important for ensuring that a PVA supports effective oversight of an external PV provider?

The vendor's preferred branding and invoice format Defined responsibilities, data flows, reporting timelines, audit rights, training expectations and business continuity arrangements A statement that the vendor may change processes without notification A general commitment to provide services at the lowest cost

Question 10 of 10 Which statement best explains why QPPV qualifications and seniority should be proportionate to the MAH's portfolio?

A more complex or higher-risk portfolio requires sufficient scientific, medical, regulatory and organisational capability to oversee a broader range of decisions and processes The QPPV must have identical qualifications to every person working in pharmacovigilance Portfolio size determines whether a QPPV needs any deputy arrangements A high-risk portfolio allows the MAH to delegate all accountability to a more experienced vendor

EU QPPV Requirements Knowledge Assessment

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