Pharmacovigilance Training

Pharmacovigilance training is a specialized educational program focused on drug safety and patient protection in the pharmaceutical and healthcare industry. It equips learners with the knowledge and practical skills needed to detect, assess, monitor, and prevent adverse effects related to medicines and vaccines throughout their lifecycle.

• Fundamentals of Pharmacovigilance: Core concepts, history, scope, and role of PV in healthcare

• Case Processing & Data Management: Practical techniques for handling safety reports, quality checks, and use of industry software (e.g., MedDRA, Argus Safety).

• Signal Detection & Risk Assessment: Methods to analyse safety data and detect potential risks or safety signals.

• Regulatory Guidelines & Compliance: Understanding of global and local regulations like ICH-GCP, Good Pharmacovigilance Practices, and regulatory reporting requirements.

  
  

• Practical Skills: Case studies, real-world examples, assignments, quizzes, and project work to enhance applied learning.

  
  

• Adverse Event (AE)/Adverse Drug Reaction (ADR) Reporting: How to identify, document, and report AEs/ADRs according to global standards.

  Key Learning Modules

  • Introduction to Pharmacovigilance and Drug Safety

  • Adverse Event and Adverse Drug Reaction Reporting

  • Individual Case Safety Report (ICSR) Processing

  • MedDRA Coding and Medical Terminology

  • Signal Detection and Risk Assessment

  • Periodic Safety Update Reports (PSUR/PBRER)

  • Risk Management Plans (RMP)

  • Regulatory Guidelines and Compliance

  • Safety Database Overview (Argus, ArisG, Veeva Safety – conceptual training)

  • Quality Assurance in Pharmacovigilance

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  Practical Training Components

  • Case narrative writing and review

  • Real-time case processing simulations

  • Literature screening and reporting

  • Follow-up documentation handling

  • Data entry and validation exercises

  • Regulatory submission workflow understanding

    he hands-on approach ensures participants are industry-ready and capable of handling real-world pharmacovigilance responsibilities.

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    Target Audience

    • B.Pharm, M.Pharm, Pharm.D graduates

    • Life Sciences graduates (BSc, MSc Biotechnology, Microbiology, Biochemistry)

    • Nursing and Medical graduates

    • Professionals seeking career transition into drug safety

      Career Opportunities After Training

      Upon successful completion, candidates can apply for roles such as:

      • Drug Safety Associate

      • Pharmacovigilance Executive

      • ICSR Processing Associate

      • Safety Data Reviewer

      • Medical Coding Specialist

      • Signal Detection Analyst (with experience)

      Pharmacovigilance remains a high-demand career domain due to increasing global regulatory scrutiny and the expansion of pharmaceutical and biotech industries.

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      Skills Developed

      • Analytical and critical thinking

      • Regulatory compliance awareness

      • Medical terminology proficiency

      • Data interpretation and reporting

      • Risk assessment capabilities

      • Documentation accuracy and quality control