Pharmacovigilance & Clinical Research
Process mock adverse-event cases, code with MedDRA and WHO-DD, write case narratives and learn ICH-GCP clinical-trial basics for drug-safety and clinical-research roles.
Talk to an advisor
Batch dates for online and offline classes.
What you'll learn
- Drug safety concepts & ICH guidelines (E2A, E2B, E2E)
- ICSR case processing, MedDRA & WHO-DD coding
- Causality assessment & case narrative writing
- Aggregate reports & signal detection basics
- Clinical trial phases, ICH-GCP, informed consent
- CRF/eCRF, SAE reporting, clinical data management basics
- Indian regulations: PvPI, CDSCO, NDCT Rules 2019
Job roles
- Drug Safety Associate
- PV Case Processor
- Clinical Research Coordinator
- Clinical Data Coordinator
Certification path
No mandatory licence for entry roles. Students complete a recognised online GCP training certificate as part of the program.
Dr. Vandana R (PT)
Anatomy & Physiology Mentor · BPT, MIMS (Maharajah's Institute of Medical Sciences), Vizianagaram
Who can join: Pharm.D, B.Pharm, M.Pharm, nursing and life-science graduates
Students join from
Pharmacovigilance & Clinical Research.
Keep medicines safe: drug safety & clinical trials
Boss projects
- 01Mock ICSR cases
- 02Case narrative portfolio
- 03GCP training certificate
What you can become
Your level map · 4 levels
- 01Wk 1–2
Drug safety basics
Pharmacovigilance conceptsICH E2A, E2B, E2EPvPI, CDSCO, NDCT Rules 2019 - 02Wk 3–4
Case processing
ICSR processingMedDRA codingWHO-DD codingUnlocks: Mock ICSR cases
- 03Wk 5–6
Assessment & reports
Causality assessmentCase narrativesAggregate reportsSignal detection basicsUnlocks: Case narrative portfolio
- Wk 7–8
Clinical research
Trial phases & ICH-GCPInformed consentCRF / eCRF & SAE reportingClinical data managementUnlocks: GCP training certificate
Who should take pharmacovigilance training?+
Pharm.D, B.Pharm and M.Pharm graduates benefit most, along with nursing and life-science graduates aiming for drug-safety or clinical-research roles.
Is pharmacovigilance training available online?+
Yes. Live online batches are open across India, with offline batches in Visakhapatnam.
Where are pharmacovigilance jobs in India?+
Hyderabad, Bengaluru, Mumbai and Chennai host most drug-safety and clinical-research teams.
