Process an ICSR end to end
Intake to closure in a real safety database, with the audit trail to show exactly what you did and when.
See how ICSR case processing worksPVgenix Academy · free & live
Learn drug safety inside a real safety database, not a slide deck.
A free, live, instructor-led programme in ICSR case processing — taught inside the GxP-aligned safety platform that pharmaceutical companies and CROs run their casework on.
No fee Free at every stageLive classes Fixed weekly scheduleHands-on access Your own environmentCertificate Issued after assessment
The workflow you will run end to endICSR lifecycle
- 01
Intake
Case received, source logged, duplicates checked, validity assessed.
- 02
Coding
Events coded in MedDRA, products in the WHO Drug Dictionary.
- 03
Quality check
Second-person review against the source document and the SOP.
- 04
E2B(R3)XML
Structured file generated, schema-checked, business rules cleared.
- 05
Submission
Transmitted to the authority; acknowledgement reconciled.
Why this exists
Our industry does not have enough well-trained drug safety people. People who have actually worked inside a real safety system are rarer still.
Why a software company runs a free academy
The teams that license PVgenix hire every time they scale, and they struggle to find candidates who can do the work on day one rather than describe it in an interview.
So we teach it ourselves, on our own platform, at no cost. There is no paid tier at the end of this page, and nothing to buy afterwards.
Interview scorecard
What a drug safety interviewer probes, and where each kind of training runs out.
| Slide-based course | PVgenix Academy | |
|---|---|---|
| Can define an ICSR and its four elements | Yes | Yes |
| Can explain seriousness and expectedness | Yes | Yes |
| Has entered a case in a safety database | No | Yes |
| Has coded an event in MedDRA | No | Yes |
| Has had their own case sent back in QC | No | Yes |
| Has cleared an E2B(R3) validation error | No | Yes |
The bottom four rows are the ones that decide interviews, and they are the four modules we run inside the platform.
What you will be able to do
Three things a hiring manager will actually test you on
Not definitions — tasks. You will have done each of these yourself, in a live system, more than once.
Code in MedDRA and WHO Drug
Choose the right MedDRA term for a reported event, code suspect and concomitant products, and handle the judgement calls that get flagged in quality review.
How AI-assisted MedDRA coding worksGenerate and check an E2B(R3) file
Produce the XML for a completed case, run schema and business-rule checks, read the errors, correct them, and complete the submission.
E2B(R2) vs E2B(R3): what changedCurriculum
Ten modules. Four of them are spent working in the platform.
Every module is taught live by someone who does this work. The hands-on modules run in your own isolated training environment.
- Live modules
- 10Live modules
- Inside the platform
- 4Inside the platform
- Final assessment
- 1Final assessment
- Total cost
- ₹0Total cost
What the syllabus covers
- Regulatory landscapeICH, EU GVP, FDA, CDSCO
- CodingMedDRA and WHO Drug
- SubmissionE2B(R3) end to end
- CompliancePart 11 and audit trails
Hands-on modules run in your own isolated environment on the platform, never in a customer's live system.
Module4 hands-on
Pharmacovigilance foundations and the global regulatory landscape — ICH, EU GVP, US FDA, CDSCO
Valid case criteria — the four elements, seriousness, expectedness, causality
Case intake and triage — spontaneous, literature, solicited and clinical trial sources, and duplicate detection
- Hands-on
Entering and completing a case in the PVgenix platform
- Hands-on
MedDRA event coding and WHO Drug Dictionary product coding
Narrative writing and the basics of medical review
- Hands-on
Quality control — reviewing and correcting someone else's case
- Hands-on
E2B(R3) XML generation, checking, and the submission workflow
21 CFR Part 11, audit trails, and what an inspector actually looks for
Career session — what a Drug Safety Associate really does in week one
What a hands-on module looks like
Module 05 · event codingPVgenix · ICSR-TRN-0148Training env
Module 05Event codingStep 2 of 4
Reported term
“red itchy patches on both forearms, started day 3”
MedDRA candidates
- Rash maculo-papularPT
- Rash pruriticPT
- Dermatitis allergicPT
E2B(R3) checks2 to clear
Audit trail
- 10:24 · Trainee 07Case created
- 10:31 · Trainee 07Term coded
- 10:36 · ReviewerQC comment
Every field change is
recorded, with the user
and the timestamp.
How it runs
Scheduled, live, and small on purpose
This is not a recorded course you work through alone. Sessions run to a timetable, with an instructor in the room.
Format
Live online classes with an instructor present — ask a question and get an answer in the session.
Schedule
A fixed weekly timetable. You choose weekday-evening or weekend when you apply, and the schedule is published before the batch starts.
Platform access
Hands-on access for the length of the programme, in a training environment that is yours alone.
Assessment
A final assessment on case processing and coding. The certificate is issued against it, not against attendance.
Your weekpick oneWeekday eveningWeekend
- Live class
- An instructor is present. Ask in the session and get an answer in the session.
- Hands-on practice
- Roughly the same time again, working cases in your own training environment.
- Sessions are taught live, not pre-recorded.
- One track only — you pick it when you apply.
- A final assessment closes the programme.
Exact days and times are published before the batch starts, so you can check them against your own timetable before committing.
Why the batch is small
Batch size is capped. Every trainee needs an isolated environment on production-grade infrastructure, and there is a real limit to how many we can run at once. When a batch fills, applications roll to the next one.
The next batch is small. Applications are open now.
It takes about two minutes to apply, and someone from the Academy team calls you back to confirm your batch.
No feeLive instructorsReal platform accessCertificate
Eligibility
Who this is for — and who it is not
We would rather you self-select out now than be disappointed in week three.
Apply if you are
- A graduate or final-year student in B.Pharm, M.Pharm, Pharm.D, MBBS, BDS, BSc/MSc Life Sciences or Nursing.
- Working in QA, regulatory affairs or medical writing and looking to move into drug safety.
- Able to attend live sessions on a fixed schedule and finish the final assessment.
Do not apply if you want
- A guaranteed job offer. We do not guarantee placement, we have no placement cell, and we will not pretend otherwise.
- A certificate without the work. The assessment is real and not everyone passes it.
- An accredited qualification. We are a software company, not a university, and this is not a degree or a diploma.
The credential
A certificate that says what you actually did
Issued after the final assessment, with a verification ID. Not a diploma and not accredited — a record of specific work in a specific system, which is exactly what an interviewer can probe.
PVgenix AcademyPVGENIX PRIVATE LIMITED
Chandigarh, India
Chandigarh, India
Certificate of Completion
ICSR Case Processing
This certifies that
Trainee Name
has completed the PVgenix Academy live instructor-led programme in Individual Case Safety Report processing and passed the final assessment, performing the work below in the PVgenix pharmacovigilance platform.
Work completed
- Processed ICSRs end to end in a GxP-aligned safety database
- Coded events in MedDRA and products in the WHO Drug Dictionary
- Performed quality-control review of another trainee's case
- Generated and checked E2B(R3) XML and completed submission
PVGENIXACADEMYVERIFIED
Programme LeadPVgenix Academy
Head of PharmacovigilancePVGENIX PRIVATE LIMITED
Verification ID PVA-0000-0000Issued DD MMM YYYY
Specimen. Real certificates carry the trainee's name, the issue date, and a unique verification ID we confirm on request.
Who teaches
Practitioners, and the engineers who built the system
Taught by people who do this work rather than by full-time trainers. Roles, not names — the mix depends on the batch.
Pharmacovigilance practitioners
Case processors, quality reviewers and medical reviewers. They teach case validity, coding judgement, narrative writing, and what gets a case sent back in review.
- Case validity
- Coding judgement
- Narratives
- QC review
Platform engineering team
The people who build and qualify PVgenix. They teach E2B(R3), audit trails, Part 11 controls, and why a GxP-aligned system behaves the way it does.
- E2B(R3)
- Audit trails
- Part 11 controls
- Data model
FAQ
Straight answers about the programme
Cost, eligibility, time commitment, and exactly what the certificate is and is not.
Something not covered here? Apply anyway and ask on the callback — the Academy team answers before you commit to a batch.
Yes. There is nothing to pay at any stage — not to apply, not to attend, and not to receive the certificate. We run the Academy because the teams who license our software need trained drug safety people, so the programme pays for itself indirectly rather than through fees.
A life-sciences or healthcare qualification, or your final year of one — B.Pharm, M.Pharm, Pharm.D, MBBS, BDS, BSc or MSc Life Sciences, or Nursing. No prior pharmacovigilance experience is needed; most trainees have none. The one hard requirement is that you can attend the live sessions.
The live sessions, plus roughly the same amount of time again on hands-on practice in your training environment. The full timetable is published before the batch starts, so you can check it against your own schedule before committing.
Fully online. Live classes from anywhere, and platform access through your browser. There is nothing to install and no travel.
No. We do not guarantee placement, we have no placement cell, and we will never promise you a job or a salary. What you get is demonstrable hands-on work in a real safety system and a certificate that lists exactly what you did. The interviews are yours to win.
PVgenix itself — the same GxP-aligned pharmacovigilance platform used for end-to-end ICSR processing, in a training environment provisioned for you. You work with real case workflows, audit trails and E2B(R3) generation rather than screenshots.
No, and we say so on the certificate itself. It is a Certificate of Completion issued by PVGENIX PRIVATE LIMITED, not a degree or a diploma, and it is not accredited by any university or government body. Its value is that it lists the specific work you completed and carries a verification ID.
You keep the certificate and its verification ID. Training-environment access ends with the batch, because each environment is provisioned for the programme itself.
Yes. Select "Still studying" as your year of passing and "Student" as your current status on the application form.
Free to read
Read ahead before the batch starts
Everything below is free to read and covers the same ground as the curriculum. Start here if you want a head start.
Applications open
Apply for the next batch
It takes about two minutes. We call you back on WhatsApp to confirm your batch and walk you through what happens next.
Seats are limited by how many isolated training environments we can run at once. If this batch is full, we roll your application to the next one.
Send someone the one-page application formPVgenix Academy is a training programme run by PVGENIX PRIVATE LIMITED. It is not accredited by, or affiliated with, any university or government body, and it does not award a degree or diploma — the credential issued is a Certificate of Completion. We do not guarantee employment or placement. MedDRA and the WHO Drug Dictionary are the property of their respective owners.
Training a team, or evaluating the platform itself?
If your organisation runs safety operations, we can walk you through the same system your trainees learn on.