Pharmacovigilance and Medical Writing
Mentor Based
Duration
10 weeks (may vary by course provider).
Eligibility
Mode
Online, with video lectures, hands-on medical writing exercises, document preparation assignments, and peer reviews.
Course Aim
This course aims to provide participants with specialized skills in medical writing for pharmacovigilance and regulatory purposes. It focuses on the creation of high-quality safety documents and reports, essential for regulatory compliance and effective communication of safety information.
Course Objectives
By the end of the course, participants should be able to:
• Understand the role of medical writing in pharmacovigilance and regulatory affairs.
• Prepare comprehensive safety documents, including Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and Safety Narratives.
• Draft clear and concise safety-related sections for regulatory submissions.
• Ensure accuracy and compliance with regulatory guidelines in medical writing.
• Communicate complex safety data effectively to diverse audiences.
• Collaborate with pharmacovigilance and regulatory teams to meet reporting deadlines.
Program Structure
The course includes specialized modules (subject to change based on the course provider), such as:
• Introduction to Medical Writing in Pharmacovigilance
• Writing Safety Narratives for Individual Case Safety Reports (ICSRs)
• Creating Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)
• Risk Management Plans (RMPs) and Benefit-Risk Assessments: Medical Writing Perspective
• Regulatory Submissions and Medical Writing for Regulatory Affairs
• Ensuring Compliance and Quality in Medical Writing
• Effective Communication of Safety Information through Writing
• Collaborative Medical Writing in Pharmacovigilance and Regulatory Affairs
What You Will Get?
Program work is completed through online system under the guidance of program coordinator.
e-LMS for smarter Learning
24 x 7 open chat box
Excellent option for summer project
Online live lectures from the experts
Prepare real time projects
Certificate on project completion
Various Job Opportunities
This course is suitable for pharmacovigilance professionals, medical writers, regulatory affairs specialists, and individuals interested in the field of medical writing for drug safety and regulatory compliance.
Steps For Enrollment
Step 1: Click On The Below Mentioned Link “Apply Here”
Step 2: Fill All Basic Details Of Yours (Name, Email Id, Contact Details, Image)
Step 3: Choose Your Program, Session And Duration Of Program
Step 4: Fill Payment Details In The Form And Submit
Step 5: Hurray! You Will Get Your Login Credential Within 48 Hrs.
Skills to Score
Fee Plan
Basic Course
3 Month Mentor Based Course
INR 12,999/- or USD 199
- Access to e-LMS
- Immediate commencement
- Study material at your doorstep
- Project Guidance from Subject Experts
- Paper Publication Opportunity
- Self Assessment
- Final Examination
- Printed certification
- Printed Marksheet
Advanced Course
6 Month Mentor Based Course
INR 22,999/- or USD 349
- Access to e-LMS
- Immediate commencement
- Study material at your doorstepv Complete Basic Course
- Complementary Scientific Technical Writing
- Real Time Project for Dissertation
- Project Guidance from Subject Experts
- Paper Publication Opportunity
- Self Assessment
- Final Examination
- Printed certification
- Printed Marksheet
Course Outcomes
• Upon completing this course, participants are expected to:
• Possess specialized skills in medical writing for pharmacovigilance and regulatory purposes.
• Be able to prepare high-quality safety documents, including PSURs, RMPs, and Safety Narratives.
• Draft safety-related sections for regulatory submissions that are accurate and compliant with guidelines.
• Communicate complex safety data effectively to diverse audiences through written reports.
• Collaborate with pharmacovigilance and regulatory teams to meet reporting deadlines and maintain quality standards.
Join Now!
It’s time for you to be enhance your knowledge and be an edge above others. Register yourself and get started today.