Pharmacovigilance & Drug Safety

Bridge skills

Medical terminology; ICSR; MedDRA; narratives; GVP

Competencies

• Adverse-event and ICSR fundamentals

  Recognize valid-case elements and follow the case lifecycle.

• Medical terminology

  Interpret clinical terms, history, products and events accurately.

• MedDRA concepts and coding judgement

  Understand hierarchy and select appropriate coding concepts.

• Seriousness, expectedness and causality

  Apply definitions consistently and document rationale.

• Case narrative writing

  Write chronological, accurate and concise narratives.

• Case quality control and data integrity

  Check completeness, consistency, traceability and accuracy.

• Regulatory timelines and GVP awareness

  Understand why reporting timelines and controlled procedures matter.

• Safety database and workflow awareness

  Understand intake, workflow states, audit trail and outputs.

• Communication and follow-up

  Write clear follow-up queries and escalate safety-critical issues.

• Literature surveillance concepts

  Screen literature and recognize potentially reportable information.

Practice labs

• Minimum Criteria and Follow-up

  Do not invent facts; clearly distinguish known, missing and assumed information.

• Narrative and Case QC

  Do not make medical conclusions beyond the provided facts.