Pharmacovigilance Data Analysis and Reporting
Mentor Based
Duration
12 weeks (may vary by course provider).
Eligibility
Mode
Online, with video lectures, hands-on data analysis exercises, case studies, and regulatory reporting simulations.
Course Aim
The aim of this course is to equip participants with advanced skills in analyzing pharmacovigilance data and preparing comprehensive safety reports. It focuses on data analysis techniques, signal detection, and effective reporting to ensure regulatory compliance and patient safety.
Course Objectives
• By the end of the course, participants should be able to:
• Analyze pharmacovigilance data using advanced statistical methods.
• Identify and investigate safety signals in large datasets.
• Develop safety surveillance plans for ongoing monitoring.
• Prepare regulatory reports, including Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Communicate safety findings to regulatory authorities and internal stakeholders.
• Implement best practices for data quality and integrity.
Program Structure
The course includes advanced modules (subject to change based on the course provider), such as:
• Advanced Data Analysis Techniques in Pharmacovigilance
• Signal Detection and Data Mining in Safety Data
• Safety Surveillance Plans and Risk Evaluation Strategies
• Regulatory Reporting Requirements and Guidelines
• Advanced Safety Data Visualization and Interpretation
• Communicating Safety Findings to Regulatory Authorities
• Ensuring Data Quality and Integrity in Pharmacovigilance
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 designed for pharmacovigilance professionals, data analysts, regulatory affairs specialists, and individuals responsible for data analysis and reporting in the pharmaceutical industry.
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
or
- 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
or
- 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 advanced skills in analyzing pharmacovigilance data using statistical methods.
• Be proficient in identifying and investigating safety signals in large datasets.
• Develop comprehensive safety surveillance plans for ongoing monitoring.
• Prepare regulatory reports, including PSURs and RMPs, accurately and in compliance with guidelines.
• Effectively communicate safety findings to regulatory authorities and internal stakeholders.
• Implement best practices to ensure data quality and integrity in pharmacovigilance activities.
Join Now!
It’s time for you to be enhance your knowledge and be an edge above others. Register yourself and get started today.
