Pharmacovigilance Training: Mastering Drug Safety from Discovery to Post-Market Monitoring

Pharmacovigilance plays a vital role in ensuring that medications remain safe and effective throughout their lifecycle. It involves the continuous monitoring, identification, and prevention of adverse drug reactions—starting from clinical trials through post-market surveillance. With growing emphasis on patient safety and compliance, trained Pharmacovigilance professionals are highly sought after across the pharmaceutical industry.

Why Choose Nen Pharma and Healthcare Pvt. Ltd.?

Our Pharmacovigilance program offers a perfect blend of in-depth theory and real-world applications. Designed and delivered by experts with extensive industry experience, this course empowers you with the knowledge and tools needed to pursue a successful career in drug safety and regulatory affairs.

Course Highlights

• ✅ Introduction to Drug Safety and Pharmacovigilance: Understand the core concepts, global regulations, and the role of Pharmacovigilance in healthcare.
• ✅ Drug Development & Safety Integration: Learn how safety is integrated across all phases of drug development, from research to marketing approval.
• ✅ Drug Safety in Clinical Trials and Marketed Products: Explore methods of safety surveillance during and after clinical trials.
• ✅ Adverse Event Reporting: Get hands-on knowledge of AE sources, types, and global reporting forms.
• ✅ Expedited Reporting & Timelines: Understand regulatory timelines and reporting mechanisms across different regions.
• ✅ Practical Case Assessment: Learn how to analyze seriousness, causality, reportability, and expectedness of adverse events.
• ✅ Narrative Writing & Causality Analysis: Master structured case narrative writing and relationship assessment between drug and AE.
• ✅ MedDRA & WHODD Coding: Familiarize yourself with international medical coding systems for safety data.
• ✅ Oracle Argus Safety Software: Introduction to the most widely used Pharmacovigilance system in the industry.
• ✅ Roles of CROs & Sponsors: Understand job roles and responsibilities in Clinical Research Organizations and pharma sponsors.
• ✅ PSUR and DSUR Reporting: Learn how to prepare periodic and developmental safety update reports in compliance with regulations.

Course Duration & Format

• Total Duration: 45 Hours
• Schedule: 45 Days (Flexible learning pace)
• Delivery: Interactive theory, case-based workshops, and practical exercises

Who Can Join?

• ✅ Life Sciences, Pharmacy, or Biotech Graduates
• ✅ Clinical Research Professionals
• ✅ Healthcare Workers and Medical Professionals
• ✅ Individuals aiming for a Pharmacovigilance or regulatory career

At Nen Pharma and Healthcare Pvt. Ltd., our goal is to deliver a transformative learning experience that not only provides a certificate but equips you with the confidence to take on real-world Pharmacovigilance responsibilities.