Yamini Alavalapati

• Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timelines and quality.
• Evaluate and finish processing of non-expeditable adverse event reports.
• Use medical dictionaries (MedDRA) to code medical history, drugs and adverse event terms.
• Prepare narratives summarizing the essential details of the case.
• Ensure timely submission of reports to regulatory bodies and that all inquiries from the FDA are responded to in a timely manner.

• Played a key role in maintaining an up-to-date knowledge base on evolving regulations and industry best practices in pharmacovigilance.
• Mentored junior staff members in pharmacovigilance best practices, fostering a culture of excellence and continuous learning.

GPA: 69%

GPA: 90.59%

GPA: 87%