AI5 PROFESSIONAL CERTIFICATE · BY TGC INDIA · UPDATED AUGUST 2026
AI for Pharmacovigilance and Drug Safety
Use AI for adverse-event case processing, literature screening, safety-signal support and regulated drug-safety documentation.
Online + OfflineWeekdays + WeekendsRegular + Fast Track
22+years in training
20,000+learners across TGC
5classroom locations
Live onlinejoin from anywhere
NEXT START OPTIONS
Choose a live batch.
COURSE OVERVIEW
What this course
is built to do.
Use AI to assist adverse-event intake, case review, literature screening, signal support and safety documentation within a traceable, human-reviewed process.
Each module combines a live trainer demonstration, guided lab, assignment and review before the next stage.
CONNECTED CAREER DIRECTIONS
Drug Safety AssociatePV Operations SpecialistSafety Data AnalystMedical Literature Associate
IS THIS COURSE RIGHT FOR YOU?
Choose it for the right reason.
You work in or want to enter pharmacovigilance associates
You want training built around professional tasks rather than generic prompts
You need human review, evidence and operating controls alongside AI tools
YOUR LEARNING ARC
From guided foundation to finished work.
Context
Map the work, data, decisions and limits.
Tools
Use the main platforms on guided cases.
Workflow
Join the tools into a repeatable, reviewed process.
Capstone
Present an industry case with evidence and controls.
INDUSTRY TASKS
Practise the work, not only the tool.
- Analyse a realistic case or operating dataset
- Build a repeatable AI-assisted workflow
- Set review, escalation and quality rules
- Present a decision-ready capstone
PRO
LED
LED
YOUR TRAINING TEAM
Learn from experienced working professionals.
Live demonstrations, guided practice and direct project feedback are part of the course. Trainers update examples and tool coverage as professional practice changes.
TRAIN A PROFESSIONAL TEAM
Run this programme around your tools and operating controls.
Private weekday, weekend and fast-track formats are available for organisations.
WHAT YOU WILL BE ABLE TO DO
Course outcomes
01
Structure safety cases
A complete case worksheet with queries and review points.
02
Screen literature reliably
A source-linked screening log.
03
Support signal review
A cautious evidence briefing with stated gaps.
04
Maintain an audit trail
A capstone showing checks, approvals and traceability.
TAKE THE NEXT STEP
Need fees, syllabus or the right batch?
An AI5 Academy advisor can help you compare mode, schedule and starting level.
DETAILED COURSE FLOW
5 learning modules
Build a traceable drug-safety workflow from adverse-event intake through case review, literature screening and signal-support reporting.
PV process, data and responsible AI
Define the safety workflow and what remains a qualified human decision.
CORE TOPICS
- ICSR lifecycle
- MedDRA and WHODrug context
- Privacy and validation
- Audit-ready AI use
GUIDED PRACTICE
Map a safety case and mark automation, review and escalation points.
MODULE DELIVERABLE
PV control map
Adverse-event intake and case processing
Structure incoming information and identify missing or conflicting fields.
CORE TOPICS
- Minimum case criteria
- Narrative extraction
- Seriousness and expectedness support
- Duplicate and follow-up cues
GUIDED PRACTICE
Process a synthetic intake set and create a query list for missing information.
MODULE DELIVERABLE
Structured case worksheet
Literature screening and evidence review
Find and screen medical literature while preserving source traceability.
CORE TOPICS
- Search strategies
- Abstract and full-text screening
- Causality evidence
- Citation checking
GUIDED PRACTICE
Create a screened literature set with reasons for inclusion and exclusion.
MODULE DELIVERABLE
Literature review log
Signal support and safety reporting
Summarise patterns without overstating causality.
CORE TOPICS
- Case series and trend summaries
- Disproportionality concepts
- Signal validation support
- Aggregate report sections
GUIDED PRACTICE
Prepare a signal-review briefing with evidence gaps and next actions.
MODULE DELIVERABLE
Safety signal briefing
Drug-safety capstone
Run a complete supervised PV case and signal workflow.
CORE TOPICS
- Case intake
- Literature evidence
- Quality checks
- Governance and handover
GUIDED PRACTICE
Present the case, signal rationale, limitations and review trail.
MODULE DELIVERABLE
Pharmacovigilance capstone
HOW THE TRAINING WORKS
Learn it. Apply it. Get it reviewed. Improve it.
Every important skill moves through explanation, demonstration, guided use and independent application. Trainer feedback is used to revise the work before it becomes part of the final portfolio.
Concept briefing
The trainer explains the principle, use case, limitations and the quality standard expected.
Live demonstration
A complete task is demonstrated while the trainer explains decisions, checks and common mistakes.
Guided lab
Learners repeat the method with support, ask questions and correct problems during the session.
Applied assignment
The same method is used on a different brief so the learner must make independent decisions.
Review and revision
Work is checked against a rubric, revised after feedback and prepared for project presentation.
PROGRESS IS CHECKED THROUGHClass exercisesModule deliverablesProject reviewsFinal capstone presentation
PORTFOLIO WORK
Projects you can show
Guided practice brief
Plan, produce, test and present a finished piece with trainer feedback.
Individual application
Plan, produce, test and present a finished piece with trainer feedback.
Workflow build
Plan, produce, test and present a finished piece with trainer feedback.
Industry-style assignment
Plan, produce, test and present a finished piece with trainer feedback.
Quality review
Plan, produce, test and present a finished piece with trainer feedback.
Final capstone
Plan, produce, test and present a finished piece with trainer feedback.
TAKE THE NEXT STEP
Need fees, syllabus or the right batch?
An AI5 Academy advisor can help you compare mode, schedule and starting level.
TOOLS COVERED
Veeva Vault SafetyArgus SafetyMedidataPython
Tool coverage may be updated when the industry changes. Core methods remain part of the course.COMMON QUESTIONS
Before you apply
Is this a generic AI course?
No. Examples, projects and review criteria are tied to the named industry workflow.
＋Can a company request a private batch?
Yes. The course can be adapted to approved tools, policies and role levels without using confidential data in open exercises.
＋Do I need coding experience?
No, unless the course level says otherwise. Your advisor will check the right starting level.
＋Are classes live or recorded?
Classes are trainer-led in the classroom or live online. Recordings may support revision but do not replace class.
＋Will I receive a certificate?
Yes. Course completion requires attendance, assignments and the final project.
＋Can working professionals join?
Yes. Weekday, weekend and selected fast-track schedules are available.
＋NEXT BATCH
Choose your course.
Choose your schedule.
Online or offline. Weekdays or weekends. Regular or fast track. Speak with an AI5 Academy advisor about the right starting level.