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Medical
Pharmacovigilance
Pharmacovigilance
Curriculum
6 Sections
22 Lessons
10 Weeks
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Module 1: Introduction to Pharmacovigilance (Week 1-3)- 6 hours
5
1.1
Basics of Drug Safety & Pharmacovigilance
1.2
Understanding Adverse Drug Reactions (ADR) & Drug Safety Monitoring
1.3
Pharmacovigilance in Drug Development & Clinical Trials
1.4
Regulatory Guidelines: ICH-GCP, WHO, US FDA, EMA, CDSCO
1.5
Hands-on: Analyze ADR Reports from Real-World Cases
Module 2: Adverse Event (AE) & Serious Adverse Event (SAE) Reporting (Week 4-7)- 6 hours
4
2.1
Case Processing Workflow & Causality Assessment
2.2
Spontaneous Reporting Systems (SRS) & Signal Detection
2.3
Hands-on: Fill & Analyze MedWatch & CIOMS Forms
2.4
Understanding MedDRA (Medical Dictionary for Regulatory Activities)
Module 3: Regulatory Compliance & Risk Management (Week 8-10)-6 hours
4
3.1
Post-Marketing Surveillance & Risk-Benefit Assessment
3.2
Pharmacovigilance Systems & Data Collection Methods
3.3
Periodic Safety Update Reports (PSURs) & Risk Evaluation (REMS)
3.4
Hands-on: Prepare a PSUR Report for Regulatory Submission
Module 4: Pharmacovigilance Databases & Software (Week 11-13)- 6 hours
3
4.1
Introduction to Drug Safety Databases (Oracle Argus, ARISg, LSMV)
4.2
E2B Guidelines & Electronic Submission of Safety Data
4.3
Hands-on: Use Pharmacovigilance Software for Case Management
Module 5: Advanced Pharmacovigilance & Signal Detection (Week 14-16)-6 hours
3
5.1
Risk Mitigation & Signal Detection Using Data Mining Techniques
5.2
Good Pharmacovigilance Practices (GVP) & FDA Regulations
5.3
Hands-on: Analyze Clinical Safety Data for Signal Detection
Capstone Project & Certification Prep (Final 4 Weeks)
3
6.1
Real-World Pharmacovigilance Case Study & Drug Safety Report
6.2
Mock Certification Exam (DIA, ACRP, PV Professional Certification)
6.3
Resume & Interview Preparation for Drug Safety & PV Roles
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