The Pharmacovigilance Process: ICSR Case Processing Step by Step

What is the pharmacovigilance process?

The pharmacovigilance process is the set of steps a drug safety team follows for every report of a suspected side effect. Each report becomes an individual case safety report (ICSR). The goal is simple: make sure every valid case is checked, recorded and sent to the right regulator on time, so that new risks are spotted early.

Reports arrive from many places: doctors, pharmacists, nurses and patients, clinical trials, studies after launch, medical journals, regulators and business partners. For a short overview of drug safety, read our beginner’s guide to pharmacovigilance. This article goes deeper into each step.

The pharmacovigilance process in 11 steps

1. 1

   1. Receive the report

   Log the report from email, phone, a form, a literature search or a partner. Note the date it arrived.

2. 2

   2. Check validity

   Under ICH E2D, a valid case needs an identifiable patient (for example initials, age or sex), an identifiable reporter, a suspect medicine and an adverse event. If one is missing, follow up before the case can go further.

3. 3

   3. Set day zero

   Day zero is the day the company first has all four minimum details. The reporting clock starts here, even if the case reached a partner or another team first.

4. 4

   4. Check for duplicates

   Search the safety database so the same patient and event are not counted twice, for example when both a doctor and a patient report it.

5. 5

   5. Triage

   Decide how urgent the case is: is it serious, is the reaction expected, and does it come from a trial or from use after launch? Serious, unexpected cases go first.

6. 6

   6. Enter the data

   Record patient details, medicines, events, dates, tests and outcome in the safety database, using the ICH E2B electronic format.

7. 7

   7. Code the case

   Code events and medical history with MedDRA, and medicines with the WHO Drug Dictionary, so cases can be searched and compared.

8. 8

   8. Assess the case

   Confirm seriousness, check expectedness against the reference safety information and assess causality: could the medicine have caused the event?

9. 9

   9. Write the narrative

   Summarise the case in clear, time-ordered English: who the patient is, what was given, what happened, what was done and the outcome.

10. 10

    10. Quality check and medical review

    A second person checks the data entry and coding. A medical reviewer confirms the assessment for serious cases.

11. 11

    11. Submit and follow up

    Send the case to regulators within the deadline, then ask the reporter for missing details and update the case as new information arrives.

Seriousness, expectedness and causality explained

Seriousness. An adverse event is serious if it results in death, is life-threatening, needs or prolongs hospital care, causes lasting disability, causes a birth defect, or is another medically important event. Serious is not the same as severe: a severe headache is usually not serious.

Expectedness. A reaction is expected if it is already listed in the reference safety information: the investigator’s brochure for a medicine in trials, or the approved label for a marketed medicine. Unexpected reactions matter most, because they may point to a new risk.

Causality. Reviewers judge whether the medicine could have caused the event. Many teams use the WHO-UMC causality system, which grades cases as certain, probable, possible, unlikely, conditional or unassessable, based on timing, other causes and what happened when the medicine was stopped or restarted.

How MedDRA coding works in the pharmacovigilance process

MedDRA is the medical dictionary used worldwide for adverse events. It has five levels: System Organ Class, High Level Group Term, High Level Term, Preferred Term and Lowest Level Term. Case processors usually pick the Lowest Level Term closest to the reporter’s words, and the dictionary links it up the hierarchy.

For example, a patient who says “my skin came out in itchy red bumps” might be coded to the Lowest Level Term “Rash pruritic”. Want to build this skill? See our MedDRA coding training.

Reporting timelines: India and worldwide

In India, clinical trial SAE reports go to CDSCO through its SUGAM portal, as set out in CDSCO’s SAE reporting guidance. For medicines already on the market, companies report to regulators and to India’s Pharmacovigilance Programme under their own national rules. Missing a deadline is a compliance failure that inspectors look for.

A worked example of the pharmacovigilance process

Here is how one made-up case moves through the steps:

1. 1A pharmacist emails the company: a 58-year-old man was admitted to hospital with severe dizziness and fainting three days after starting a new blood pressure medicine.
2. 2Validity: patient (58-year-old man), reporter (pharmacist), suspect medicine and event are all present, so day zero is the day the email arrived.
3. 3Triage: hospital admission makes it serious. Fainting is not in the product label, so it is unexpected. It goes to the top of the queue.
4. 4Coding: “fainting” is coded to the MedDRA term Syncope, and “severe dizziness” to Dizziness.
5. 5Causality: the event started soon after the medicine and improved when it was stopped, so the reviewer grades it as probable.
6. 6Narrative and submission: the processor writes the narrative, a second person checks it, and the case is sent to the regulator within 15 calendar days of day zero.
7. 7Follow-up: the team asks the pharmacist for the hospital discharge summary and updates the case when it arrives.

What happens after case processing

Single cases are only the start. Safety scientists look across many cases to find new risks (signal detection) and write periodic reports that review a medicine’s whole safety picture, such as the PBRER under ICH E2C(R2). Risk management plans then decide what to do, for example adding a warning to the label.

Most people enter drug safety by doing the case processing steps above as Drug Safety Associates. See where the work leads in our pharmacovigilance career path guide.

Learn the pharmacovigilance process hands-on

BCRI’s pharmacovigilance course teaches this process on a real safety database (Clinevo), with case processing, MedDRA coding and narrative writing practice. It runs for 2 months, live online or in Bangalore, and the fee is ₹22,500. For more database practice, see the PV database training course.

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