This 12-week online internship is designed for students and early professionals interested in gaining hands-on experience in the field of pharmacovigilance, specifically focusing on the preparation of critical safety reports such as Development Safety Update Reports (DSUR), Periodic Adverse Drug Experience Reports (PADER), and Periodic Safety Update Reports (PSUR) / Periodic Benefit-Risk Evaluation Reports (PBRER). Throughout the course, interns will engage in a comprehensive learning experience that covers the essential aspects of pharmacovigilance reporting. Participants will develop a deep understanding of the regulatory requirements and best practices for compiling and submitting safety reports to regulatory agencies. Key Learning Objectives:
- Understanding Pharmacovigilance: Gain insights into the role of pharmacovigilance in drug safety monitoring and the importance of aggregate reporting in ensuring patient safety.
- Report Preparation: Learn the methodologies for preparing DSUR, PADER, PSUR, and PBRER.
- Regulatory Compliance: Familiarize yourself with the regulatory frameworks governing safety reporting across different regions, including the specific requirements for each type of report.
- Practical Skills: Develop practical skills in writing and editing safety reports, focusing on clarity, accuracy, and compliance with regulatory standards.
Interns will work closely with experienced professionals in the field that enhance their understanding of pharmacovigilance processes. This internship not only provides valuable experience but also prepares participants for future roles in the pharmaceutical and healthcare industries, where safety reporting is a critical component of drug development and post-marketing surveillance. By the end of the internship, participants will have a solid foundation in pharmacovigilance reporting and be well-equipped to contribute to safety monitoring efforts in their future.
