Tirupathi Rao Edubilli

Associate Director Safety @Roche

Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER). • Responsible for signal detection and management activities including. Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests. •In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC) and other internal and external review and governance committees as needed. • Contributing to study management from a safety perspective through SMT activities and document review and maintenance across the development continuum (early phase to post marketing studies), including PASS. • Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable • Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with SSL. • Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals. • Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including the IB), risk communications, RMP, REMS. • Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB.