Pharmacovigilance

Preamble

With increase of drug safety concerns as well as enhanced clinical trial and strict regulatory enforcements the role of pharmacovigilance has increased tremendously. IT interface development, software tools, AI tools and data management has made pharmacovigilance turning out to be a professional career. Pharmaceutical industry dependance on pharmacovigilance also providing boost for such a career path

Training Outcomes

• Salient aspects of the Life Sciences (especially Pharmaceutical and Bio Pharmaceutical) Industry and its pertinent regulations in order to demonstrate performance that is in line with industry standards.

• Understanding of the principles, importance, and regulatory framework of pharmacovigilance, including the role of artificial intelligence in drug safety.

• Perform the collection, processing, and assessment of Individual Case Study Reports (ICSRs).

• Perform writing aggregate safety reports (PSURs, PADERs, PBRERs, RMPs, Signal management reports).

• Perform pharmacovigilance literature search activities

• Perform various pharmacovigilance activities (Case processing, Aggregate safety report, Signal management report writing activities) using software and drug safety databases

• Ensure regulatory compliance by compiling, identifying, and improving issues in regulatory compliance of ICSRs.

• Synchronize work with medical reviewer, safety physicians, supervisors and, cross- functional teams and auditors to achieve work goals

• Competence in integrating artificial intelligence into various aspects of pharmacovigilance, from adverse event identification to regulatory reporting and signal detection efficient and accurate case processing, including data entry, causality assessment, and quality control, 

• Using some AI tools and ability to leverage such AI tools for enhanced productivity

Eligibility

• Completed B.Sc (Microbiology) / B. Pharma / B. Tech (Biotech) / B.Sc Biotechnology (Indian / foreign universities)

OR

• Completed or Final year MBBS/BDS/BPT/BOT/BAMS/BHMS (in any medical subject)/ (Indian / recognized foreign universities)

Course Anatomy

• Total duration of the course : 330 hours (of theory and practical sessions) PLUS Capstone Project 60 hours

• Theory - 180 hours : Practical, Project assignments - 150 hours 

 Course structure

• Extensive demo and exercise

• Several projects on use of various tools

• Capstone project

Training Delivery

• In Hybrid Mode with offline classes from campus with remote access through smart classroom

• Managed through a LMS platform with separate web page for each batch

Training Input

• All digital content available through web page of the batch

Lesson Planning

• Flexible  structure customised each week while making the weekly roster.

Broad Coverage

Module 1 - Orientation to the Life Sciences industry and its job role

Module 2 :Basic Principles of Clinical Pharmacology and Drug Action : NOS Code LFS/N0509

Module 3 : Introduction to Clinical Research : NOS Code LFS/N0509

Module 4 : Basics of Pharmacovigilance and key Processes Mapped to LFS/N0702, v1

Module 5 : Regulatory Framework and Reporting Requirements for pharmacovigilance

Module 6 : Adverse Event Identification and Data Sources

Module 7 : Global/Local Medical Literature Surveillance  : Mapped to LFS/N0702, v1

Module 8 : Individual Case Safety Reports (ICSRs) processing : Mapped to LFS/N0702, v1

Module 9 : Writing aggregate safety reports including PSURs, PADERs, RMPs, Signal Management Reports

Module 10 : Pharmacovigilance Software Tools and AI Integration

Module 11 : Safety Databases and Other Associated Tools : Mapped to LFS/N0705, v1

Module 12 : Introduction to AI for Pharmacovigilance and  Drug Safety

Module 13 : Software Validation and Artificial Intelligence (AI) in Pharmacovigilance : Mapped to LFS/N0705, v1

Module 14 : Regulatory Reporting and Case Processing Workflow with AI

Module 15 : Pharmacovigilance Quality Management System (PQMS) : Mapped to LFS/N0703, v1

Module 16 : Regulatory Compliance in Pharmacovigilance : Mapped to LFS/N0703, v1

Module 17 : Coordination with Medical Coder/ Reviewer, Safety Physicians, Supervisors, and Cross-Functional teams and auditors : Mapped to LFS/N0704, v1

Module 18 : Bio Ethics

Module 19 : Managing environmental sustainability  : Mapped to LFS/N0119, v2

Module 20 : Display sensitivity towards all genders and people with disability : Mapped to LFS/N0119, v2

Module 21 : Employability Skills Mapped to DGT/VSQ/N0102- v1.0

Delivery

• Interactive theoretical sessions to cover fundamental and advanced concepts.

• Practical sessions in a controlled environment to apply theoretical knowledge.

• Real-world scenarios to enhance problem-solving skills.

• A comprehensive project to apply learning in a practical, real-world context.

• Regular quizzes, assignments, and exams to evaluate understanding and progress.

• Practical sessions will include hands-on exercises with software  tools and AI applications connected to Pharmacovigilance,