Pharmacovigilance Training in Bangalore

Pharmacovigilance Course Overview

Industry-Oriented Pharmacovigilance Training | Drug Safety | Practical Case Processing

Pharmacovigilance is a critical and evolving field within healthcare and the pharmaceutical industry focused on the monitoring, assessment and prevention of adverse effects and other drug-related problems. It plays an important role in supporting the safety and effective use of medicines for patients worldwide.

Skillbee Solution provides Pharmacovigilance Training in Bangalore for learners seeking practical knowledge of drug safety, clinical-trial safety, adverse-event processing, regulatory reporting and global safety databases. The Bangalore-focused page prioritizes the city while retaining online learning flexibility.

The Skillbee Solution programme is designed to build practical understanding of the drug-safety lifecycle, including adverse-event receipt, triage, case processing, medical review, coding, narrative writing, regulatory reporting, signal detection and risk management. Theory is supported by case studies and practical exposure to safety-database workflows.

Why Build a Career in Pharmacovigilance?

Drug safety requires professionals who can understand medical information, follow controlled processes, maintain data quality and work within regulatory requirements. Career paths may begin with roles such as Drug Safety Associate, Pharmacovigilance Associate, Drug Safety Officer, Scientist or Coordinator and progress toward specialist, medical writing, quality, compliance and management functions.

Key Learning Areas

• Pharmacology, clinical trials and pharmacovigilance
• Adverse drug reactions and safety reports
• Case receipt, triage and case processing
• Seriousness, expectedness and causality assessment
• MedDRA and WHO Drug coding
• Narrative writing and case quality checks
• Medical review and case submission
• Safety databases and pharmacovigilance workflows
• Expedited reporting and timelines
• Aggregate safety reports, PSUR and DSUR
• Signal detection and data mining
• Global pharmacovigilance regulations
• PVPI, QPPV and regulatory authorities
• Practical software and case-study exposure

Certified Study Course – Modules

Module 1: Introduction to Pharmacology, Clinical Trials and Pharmacovigilance

Module 2: Adverse Drug Reactions and Safety Reports

Module 3: Methodologies in Pharmacovigilance

Module 4: Management Systems and Drug Dictionaries – Argus, ArisG, MedWatch, MedDRA, WHODD

Module 5: Seriousness, Expectedness and Causality Assessment Criteria

Module 6: Aggregate Safety Reports

Module 7: Pharmacovigilance Regulations in Various Countries

Module 8: Pharmacovigilance Programme in India (PVPI)

Module 9: Signal Detection and Data Mining

Module 10: Pharmacovigilance of Herbal Drugs and Medical Devices

Module 11: Pharmacovigilance Compliance and Inspections

Module 12: Hands-on training on Argus, ArisGlobal, ABcube and related platforms

Module 13: Case Study

Detailed Training Topics

1. Welcome, history and overview of pharmacovigilance
2. Drug development and clinical trial phases
3. PV roles and responsibilities in CROs and sponsors
4. PV process and lifecycle
5. USFDA, EMA and CDSCO
6. Pharmacovigilance in India
7. Clinical development process
8. Clinical-trial phases
9. Adverse events and types
10. Drug safety in clinical trials and post-marketed drugs
11. Sources of adverse-event reporting
12. Types of AE reporting forms
13. Expedited reporting and timelines
14. Departments working on pharmacovigilance
15. Case Receipt Unit responsibilities
16. Triage Unit responsibilities
17. Four factors for a reportable case
18. Seriousness criteria
19. Expectedness/Listedeness
20. Causality assessment
21. Safety databases
22. Narrative writing
23. Case quality check, medical review and submission
24. QPPV in the EEA
25. PSUR and submission timelines
26. Regulatory authorities
27. ICH GCP guideline

Practical Training – Safety Database

Practical exposure is provided around core drug-safety activities and the workflow of a global safety database.

• Case processing
• MedDRA coding & WHO Drug coding
• Duplicate check and case initiation
• SAE narrative writing

Pharmacovigilance Case-Processing Workflow

Participants are introduced to the relationship between case receipt, triage, reportability, data entry, coding, narrative writing, quality/medical review and submission.

Benefits of the Course

• Complete course material covering the Drug Safety Associate workflow
• 2-month internship after rigorous training in Pharmacovigilance
• Own CRO live projects
• Real-time global drug-safety software exposure with PSUR & DSUR training
• Industry-based SOP training
• Trainers with minimum 7+ years of experience as stated in the supplied content
• Medical-doctor-led teaching support
• Hands-on global safety database exposure
• Up to 150 hours of theory, case studies and practicals as stated in the supplied content
• Practical case processing, narrative writing, MedDRA and WHO Drug coding

Eligibility

Graduation / B.Tech / B.Sc. in Microbiology, Life Sciences, Botany, Zoology, Food Science, Food Technology, BE, B.Pharma, MBBS, BDS, BHS, BUMS, BAMS or another relevant discipline. Diploma holders may be eligible for applicable Executive Diploma, Industry Certificate and Certification in Pharmacovigilance programmes.

Career Opportunities

• Drug Safety Associate / Officer
• Pharmacovigilance Associate
• Senior Pharmacovigilance Specialist
• Drug Safety Consultant
• Drug Safety Manager / Director
• Drug Safety Physician
• Medical Writer
• PV Quality / Compliance roles
• Signal Detection and Risk Management roles

Upon Successful Completion

• Resume Preparation
• Interview Preparation and Mock Interview Session
• Communication Skills and Personality Development Sessions
• Placement Assistance

Programme Deliverables

• Comprehensive soft-copy study material
• Assignments for continuous evaluation
• Interactive online live sessions
• Doubt-clearing support
• Faculty guidance
• Assessment and evaluation
• Participant feedback
• Training delivery in English

Assessment & Certification

Participants are expected to complete the applicable online assessment. After successful qualification, certification is provided by Skillbee Solution according to programme requirements.

Placement Assistance & Corporate Relations

Skillbee Solution provides placement assistance and career-oriented support. The supplied programme content references organizations including IQVIA, Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, IPCA Laboratories, Calyx, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy and Biocon, among others. Placement outcomes depend on qualifications, skills, experience and employer requirements.

Why Choose Skillbee Solution?

• Industry-oriented curriculum
• Practical case-processing exposure
• Safety database training
• Regulatory and compliance awareness
• Case studies and assignments
• Internship and live-project exposure as described in the programme
• Certification
• Placement assistance
• Online learning flexibility