Practice Test Geeks(PVC) Pharmacovigilance Certification Practice Test
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Risk Management & Signal Detection Flashcards

7 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. Which regulatory framework requires a Risk Management Plan (RMP) to be submitted alongside a Marketing Authorization Application in the EU?

    Answer: EU GVP Module V

    EU GVP Module V governs Risk Management Systems and mandates an RMP for new MAAs in the European Union.

  2. What is the minimum disproportionality threshold commonly used with the Reporting Odds Ratio (ROR) to flag a potential signal?

    Answer: ROR > 1.0 with 95% CI lower bound > 1

    A signal is typically flagged when the ROR exceeds 1.0 and the lower bound of the 95% confidence interval is also above 1.

  3. In signal management, what does the term 'signal validation' refer to?

    Answer: Assessing whether data support a causal association beyond background noise

    Signal validation evaluates whether the available data provide sufficient evidence that the detected association is more than a statistical artifact.

  4. A Risk Minimization Measure (RMM) that restricts prescribing to certified specialists is classified as:

    Answer: Additional RMM — restricted access

    Restricted access programs, such as prescriber certification requirements, are categorized as additional RMMs that control who can prescribe or dispense a medicine.

  5. Which metric does the Proportional Reporting Ratio (PRR) compare?

    Answer: Proportion of reports for a drug-event pair vs. all reports for that event across all drugs

    The PRR compares the proportion of reports for a specific drug-event combination to the proportion of the same event reported for all other drugs in the database.

  6. According to ICH E2E, which document provides the scientific rationale for proposed pharmacovigilance activities and risk minimization?

    Answer: Risk Management Plan (RMP)

    ICH E2E describes the Risk Management Plan as the document that outlines the safety specification, pharmacovigilance plan, and risk minimization strategy.

  7. A MAH conducts a Targeted Follow-up questionnaire for a specific adverse event. This is an example of:

    Answer: Additional pharmacovigilance activity

    Targeted follow-up questionnaires are additional pharmacovigilance activities used to collect more detailed information on specific safety concerns.