Master Pharmacovigilance & Medical Writing Skills
Industry-focused certification program designed to build expertise in pharmacovigilance, aggregate safety reporting, and regulatory medical writing.
✅ 90 Hours Intensive Training
✅ Real-World Case Studies & Datasets
✅ Hands-on PSUR / PBRER / DSUR Writing
✅ Industry-Aligned Curriculum
✅ Certificate Upon Completion
Mode: Classroom / Hybrid / Online
Sector: Healthcare / Life Sciences / Pharmacovigilance
About the Course
The Certificate Course in Aggregate Safety Report Writing (ASRW) is a comprehensive training programme designed for graduates and professionals aspiring to build careers in pharmacovigilance, drug safety, and medical writing.
The programme focuses on practical industry-oriented learning with exposure to real-world safety reporting workflows, regulatory frameworks, and aggregate report preparation.
Programme Highlights
Industry-Oriented Learning
Learn current pharmacovigilance practices followed by global healthcare and life sciences companies.
Practical Training
Gain hands-on experience in preparing PSUR, PBRER, DSUR, and other aggregate safety reports.
Expert Guidance
Train under experienced professionals with practical exposure to safety reporting workflows.
Real Case Studies
Work with industry datasets, reporting templates, and simulation exercises.
Flexible Learning Modes
Available in Classroom, Hybrid, and Online formats.
Certification
Receive course completion certification from Vaidyaa Clinical Services Pvt. Ltd.
Course Structure
| Component | Hours |
|---|---|
| Theory | 45 Hours |
| Practical | 35 Hours |
| Assessment | 10 Hours |
| Total Duration | 90 Hours |
Eligibility
This programme is suitable for graduates and professionals from:
- Pharmacy (B.Pharm / M.Pharm)
- Medicine (MBBS / MD)
- Nursing (B.Sc / M.Sc)
- Life Sciences
- Biotechnology
- Allied Health Sciences
Curriculum Overview
Module 1 — Introduction to Pharmacovigilance
- History & evolution of Pharmacovigilance
- Regulatory framework (ICH, WHO)
- Key terminologies & concepts
Module 2 — Adverse Event Reporting
- ICSR processing & case management
- MedDRA coding & narratives
- Causality assessment methods
Module 3 — Signal Detection & Management
- Signal identification techniques
- Data mining & statistical methods
- Signal evaluation & communication
Module 4 — Aggregate Safety Reports
- PSUR, PBRER, DSUR & PADER
- Regulatory requirements & timelines
- Report structure & components
Module 5 — PSUR/PBRER Writing
- Data collection & analysis
- Benefit-risk evaluation
- Writing sections with real data
Module 6 — DSUR & Other Reports
- DSUR structure & content
- Risk Management Plans (RMP)
- REMS & safety communications
Module 7 — Quality & Compliance
- QC/QA in safety reporting
- SOPs & regulatory inspections
- Documentation best practices
Module 8 — Practical Project
- End-to-end report writing
- Peer review & presentation
- Industry simulation exercise
Career Opportunities
After successful completion, learners can pursue roles such as:
- Drug Safety Associate
- Pharmacovigilance Scientist
- Medical Writer
- Safety Report Analyst
- Aggregate Report Specialist
- Regulatory Affairs Associate
Why Choose Vaidyaa Clinical?
- Industry-focused curriculum
- Practical exposure with live datasets
- Career-oriented training
- Experienced mentors
- Flexible learning options
- Growing demand in Pharmacovigilance industry
Assessment Methodology
| Assessment Type | Weightage |
|---|---|
| MCQs | 30% |
| Assignments | 20% |
| Case Studies | 20% |
| Practical Examination | 30% |