Pharmacovigilance Case Processing Workflow

Pharmacovigilance Case Processing Workflow: Individual case safety report processing organises suspected adverse reaction information so it can be evaluated, transmitted when required and retained in a traceable manner.

Why professionals need this knowledge: A reliable process balances speed, medical quality, confidentiality and accurate data entry across intake channels.

Step 1: Receive and assess source information, identify minimum case elements under the applicable rules and request needed follow-up.

Step 2: Code events and medicinal products consistently, evaluate timelines, duplicates and medical narratives, and apply quality review.

Step 3: Determine reportability and due dates under each applicable jurisdiction, submit through approved channels and reconcile acknowledgements.

Worked example: A social-media complaint mentions a suspected reaction without enough patient detail. Staff must follow the company's intake and follow-up procedure rather than inventing missing facts.

What to avoid: Silently changing source wording, losing original intake date, duplicating reports or assuming one country's clock applies worldwide. An apparently neat form is not a substitute for reliable actions and sound judgement in the real workflow.

Records and audit trail: Original source, intake timestamp, coding, medical review, reportability decision, submission receipt and follow-up history. Accurate records enable independent review and appropriate follow-up when concerns arise.

Try this exercise: Map the intake-to-submission path for one example report and identify each independent quality check. Discuss the exercise with an appropriately qualified colleague before applying it to a live case.

Standards and references: WHO pharmacovigilance resources, ICH E2 safety guidelines and local authority reporting rules. This is educational material; the approved protocol, governing standard and local law take precedence.