Surya Boyina

Seasoned pharmacovigilance professional, with almost 8 years of industry experience with solid knowledge of medical terminology, drug development process, adverse event processing and reporting and submission, US and global regulations. • Performed case management including receipt, triage, book-in, duplicate check, seriousness, expectedness, data entry, narratives, Follow up, QC. • Experience in assessing adverse events for Clinical/ investigational and Post-marketed drugs with respect to seriousness, relatedness, listedness in order to assign appropriate case reporting status. • Proficient in using MedDRA and WHO drug dictionary. • Expert in generating and updating narratives ensuring quality, detail, clarity and consistency according to CIOMS template and Company’s Standard Operating Procedures as applicable. • Performing Quality check of Adverse Events, Serious Adverse Events based on approved case processing metrics. • Proficient in of global safety databases like ARGUS and ARISg. • Expertise in Microsoft Word, Excel, PowerPoint, and Outlook. • Experience working in different therapeutic areas. • Working effectively with focus and great attention using experience knowledge of US FDA, EMEA and ICH- GCP guidelines and regulations governing clinical trial safety environments. • Experience working with different cross functional teams in order to ensure timely submission of documents to regulatory authorities. • Ability to work independently and also as a team player. • Effective verbal and written communication skills and able to meet strict project deadlines and guidelines.