Diploma in Pharmacovigilance & Medical Writing

Course Summary

The Advanced Diploma in Pharmacovigilance & Medical Writing (ADPV-MW) is designed to provide students a complete understanding of Pharmacovigilance processes, regulations and documentation as well as equip you with the skills required for writing clinical study reports as well as various clinical trial, regulatory and other scientific documents . It equips you to start a career in Drug Safety or as a Pharmaceutical Medical Writer. The course is aligned to the requirements of the industry and includes hands-on training modules on Oracle Argus Safety for Pharmacovigilance.

Key Features

• 24×7 access to the Oracle Argus Safety software.
• Full access to e-Learning Portal containing Multimedia Tutorials and Quizzes.
• Course Instructor support via Discussion Forums

Curriculum

• Module 1 – General Introduction
• Module 2 – Epidemiology and Evidence Based Medicine
• Module 3 – Principles of Pharmacovigilance
• Module 4 – Pharmacovigilance and Selected System Organ Classes
• Module 5 – Pharmacovigilance Systems
• Module 6 – Global Pharmacovigilance and Safety Standards
• Module 7 – Pharmacovigilance Regulations and Guidelines
• Module 8 – Pharmacoepidemiology
• Module 9 – Oracle Argus Safety Essentials
• Module 10 – Basics of Good Medical Writing
• Module 11 – Computer Skills
• Module 12 – Overview of Regulatory, Marketing and Drug Promotion Process
• Module 13 – Common Technical Document
• Module 14 – Protocol, Investigator’s Brochure and CRFs
• Module 15 – Clinical Study Report
• Module 16 – Sentence Control
• Module 17 – Writing Flow and Cohesiveness
• Module 18 – Publication Writing
• Module 19 – Documents in Medico-Marketing
• Module 20 – Managing the Review Process
• Course Completion

Certification

At the end of the course, students will be awarded a certificate of completion.

Duration:   6 months