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Pharmacovigilance Training Course | ADR Reporting & Drug Safety Certification

Pharmacovigilance Training Course | ADR Reporting & Drug Safety Certification

About This Course
Comprehensive Pharmacovigilance training for pharma, biotech, and medical graduates.
Covers drug safety, ADR detection, and regulatory compliance (FDA, EMA, CDSCO).
Learn signal detection, risk management, and global reporting standards (E2B(R3), PSURs, DSURs).
Hands-on experience with MedDRA coding, case processing, and PV tools (Argus, ArisGlobal).
Understand pharmacovigilance systems, audits, and automation using AI/ML.
Real-world case studies, mock audits, and resume preparation included.
Ideal for roles like Drug Safety Associate, PV Scientist, and Safety Data Analyst.
Stay updated on industry trends and boost your regulatory career.
What You'll Learn
  • Module 1: Understand pharmacovigilance basics, history, public health impact, and key terms (ADR, SAE).
  • Module 2: Learn drug development stages, clinical trial phases, and global regulatory frameworks (FDA, EMA, CDSCO, ICH).
  • Module 3: Identify and classify ADRs, learn detection, assessment, and reporting standards.
  • Module 4: Master case intake, medical coding (MedDRA), narrative writing, and causality assessment.
  • Module 5: Explore signal detection methods, risk management plans, and safety update reports.
  • Module 6: Grasp regulatory reporting, E2B(R3) format, timelines, and global vs. national requirements.
  • Module 7: Study PV systems, master files, audits, quality, and compliance.
  • Module 8: Use PV tools like Argus, EDC systems, and AI-based automation.
  • Module 9: Gain hands-on training with real cases, coding, signal detection, and audits.
  • Module 10: Prepare for PV careers, job roles, resume building, and industry trends.
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