Pharmacovigilance & Drug Safety Certification — Professional

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1. Module 1

   P-M1

   1 lesson · 8 h

   1. Locked.Terminology under pressure8 h · Locked

      On completion you will be able to

      • The learner can:
      • Adjudicate a terminology dispute by reference to the governing definition and its jurisdiction, and document the adjudication.
      • Draft an SOP definitions section that spans ICH, US and EU vocabularies without collapsing the differences.
      • Identify where a protocol's safety definitions conflict with regulatory ones and state the consequence.
      • Classify special situations — overdose, medication error, misuse, abuse, off-label use, occupational exposure, lack of efficacy, pregnancy exposure, transmission of an infectious agent, quality defect.
      • Determine hospitalisation edge cases and justify the determination.

2. Module 2

   P-M2

   1 lesson · 9 h

   1. Locked.Case intake, day zero and triage9 h · Locked

      On completion you will be able to

      • The learner can:
      • Design an intake workflow that protects day-zero integrity across every receipt channel.
      • Determine day zero in hard cases — contractor receipt, partner-company receipt outside the EU, literature, social media, call centre.
      • Classify an ambiguous source correctly and state the reporting consequence.
      • Specify a literature monitoring process and defend its scope.
      • Diagnose the root cause of a late-report finding.

3. Module 3

   P-M3

   1 lesson · 9 h

   1. Locked.Case processing quality and reconciliation9 h · Locked

      On completion you will be able to

      • The learner can:
      • Execute and defend a duplicate-detection process.
      • Specify safety-to-clinical database reconciliation and adjudicate its discrepancies.
      • Define compliance metrics that survive scrutiny.
      • Write a CAPA that addresses a cause rather than an instance.
      • Manage the tension between data-protection masking and identifiability.

4. Module 4

   P-M4

   1 lesson · 12 h

   1. Locked.Assessment: seriousness, expectedness, causality12 h · Locked

      On completion you will be able to

      • The learner can:
      • Adjudicate contested seriousness determinations and document the reasoning against the criterion.
      • Maintain reference safety information and determine the effect of an RSI change on reportability, prospectively and retrospectively.
      • Manage an investigator/sponsor causality disagreement without removing reportability.
      • Apply the specificity/severity rule to determine unexpectedness.
      • Determine the reporting consequence of a change on any single axis.
      • Evaluate a causality assessment method against its stated assumptions.

5. Module 5

   P-M5

   1 lesson · 8 h

   1. Locked.MedDRA in practice8 h · Locked

      On completion you will be able to

      • The learner can:
      • Code verbatim terms to LLT and defend the choice against alternatives.
      • Author a coding convention and apply it consistently.
      • Construct an SMQ-based retrieval at narrow and broad scope and state the trade-off.
      • Plan a MedDRA version upgrade and describe its effect on existing data and cumulative outputs.
      • Explain primary SOC allocation rules including the special allocations.

6. Module 6

   P-M6

   1 lesson · 5 h

   1. Locked.CTCAE in practice and the version problem5 h · Locked

      On completion you will be able to

      • The learner can:
      • Grade an event against CTCAE term-specific criteria rather than against the generic grade wording.
      • Explain why a CTCAE grade never determines seriousness.
      • Reconcile a CTCAE-graded oncology dataset with MedDRA-coded safety data.
      • Identify a version-alignment defect in a protocol or SAP.

7. Module 7

   P-M7

   1 lesson · 13 h

   1. Locked.Expedited reporting across jurisdictions13 h · Locked

      On completion you will be able to

      • The learner can:
      • Determine every reporting obligation a described case triggers, across every jurisdiction in which the product is under development or authorised.
      • Name the destination and format for each.
      • Diagnose and remediate a compliance failure against a named clock.
      • Determine whether and by whom a blinded case must be unblinded for reporting.
      • Distinguish the sponsor's regulatory obligation, the investigator's protocol obligation and the IRB/IEC requirement.

8. Module 8

   P-M8

   1 lesson · 11 h

   1. Locked.Aggregate reporting11 h · Locked

      On completion you will be able to

      • The learner can:
      • Select the correct aggregate report for a product's regulatory status and jurisdiction.
      • Determine the data lock point and reporting interval and assemble the interval and cumulative datasets.
      • Draft and defend a benefit-risk evaluation section.
      • Reconcile an aggregate report to the ICSR database.
      • Coordinate the cycle across affiliates and partners.

9. Module 9

   P-M9

   1 lesson · 11 h

   1. Locked.Signal detection and management11 h · Locked

      On completion you will be able to

      • The learner can:
      • Run and interpret a disproportionality analysis and state its limits.
      • Validate a signal and document the validation.
      • Prioritise, assess and close signals with documentation at each transition.
      • Determine what action a confirmed signal requires and by when.
      • Design a detection strategy proportionate to the product's data sources and lifecycle stage.

10. Module 10

    P-M10

    1 lesson · 6 h

    1. Locked.Risk management: RMP and REMS6 h · Locked

       On completion you will be able to

       • The learner can:
       • Critique an RMP against the product's safety specification.
       • Distinguish routine from additional risk minimisation and specify how effectiveness will be measured.
       • Describe the statutory REMS elements and distinguish a REMS from an RMP.
       • Evaluate whether a proposed risk minimisation measure is proportionate.

11. Module 11

    P-M11

    1 lesson · 4 h

    1. Locked.PV systems, the QPPV and inspection4 h · Locked

       On completion you will be able to

       • The learner can:
       • Describe the components of a pharmacovigilance system and locate a described failure within one.
       • State the QPPV's legal position accurately, including its residency, availability and delegation rules — and state what it does not mean.
       • Describe the PSMF's function.
       • Prepare for a PV inspection and respond to a finding.