Industry-Oriented Pharmacovigilance Training | Drug Safety | Practical Case Processing
Pharmacovigilance Course Overview
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.
For learners seeking Pharmacovigilance Certification Courses with Certificate, this programme provides a structured online route covering pharmacovigilance fundamentals, adverse-event processing, safety reporting, coding, regulatory requirements and practical drug-safety workflows.
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
- Welcome, history and overview of pharmacovigilance
- Drug development and clinical trial phases
- PV roles and responsibilities in CROs and sponsors
- PV process and lifecycle
- USFDA, EMA and CDSCO
- Pharmacovigilance in India
- Clinical development process
- Clinical-trial phases
- Adverse events and types
- Drug safety in clinical trials and post-marketed drugs
- Sources of adverse-event reporting
- Types of AE reporting forms
- Expedited reporting and timelines
- Departments working on pharmacovigilance
- Case Receipt Unit responsibilities
- Triage Unit responsibilities
- Four factors for a reportable case
- Seriousness criteria
- Expectedness/Listedeness
- Causality assessment
- Safety databases
- Narrative writing
- Case quality check, medical review and submission
- QPPV in the EEA
- PSUR and submission timelines
- Regulatory authorities
- 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.
| Receipt | Triage | Reportability | Data Entry | Coding | Narrative | Review | 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
Registration & Apply Online
Review the course modules, eligibility and practical learning components and register online to begin your pharmacovigilance learning journey.
Contact
Phone Number: +91-9691633901 Email ID: Info@skillbee.co.in
Frequently Asked Questions
What is Pharmacovigilance?
It is the science and activities related to detection, assessment, understanding and prevention of adverse effects and other drug-related problems.
Who can join?
Pharma, life-sciences, medical and related graduates can consider the programme subject to the stated eligibility.
Is practical training included?
Yes. The supplied content includes case processing, coding, duplicate checking, case initiation and SAE narrative writing.
Is internship available?
The supplied content states that a 2-month internship is available after rigorous training.
Which software is covered?
The content mentions Argus, ArisGlobal, ABcube, MedDRA and WHO Drug.
Is placement assistance provided?
Yes, placement assistance is included.
Is certification provided?
Yes, after successful completion of the applicable assessment and programme requirements.
Is online training available?
Yes, interactive online live sessions are included.
