Abhinav Gaddam

Medical Safety Expert @Sandoz

IN

Provide support according to the needs for delivery activities, i.e. SUSAR ICSR medical review when needed, co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.2. Assist the GPSL/MSL in monitoring the safety profile of products including with activities such as literature review, medical assessment. Perform Literature review for PSUR inclusion and assessment of literature for signals4. Provide support for the preparation of ad hoc Health Authority queries, provide input into responses to inquiries from health care professionals on safety issues5. Together with the Safety Leads, co-author the PSUR sections as required, including analytical input to PSUR for identified and potential risks defined in the Risk Management Plan (RMP) and new safety signals. Perform follow up activities on Health Authority Assessment Reports.6. Assist in evaluating and writing other safety deliverables including but not limited to Clinical Overview, Development Safety Profiling Plan (d-SPP), and Development Safety Update Report (DSUR).7. Owns the safety strategy of the assigned products and ensures ongoing evaluation of the overall safety profile, serving as the medical safety representative for Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), Annual Product Quality Reports (APQRs) and medical risk assessments (MRAs).8. Provide safety input (Addendum to Clinical Overview) for license renewal documents9. Co-author medical assessment of product quality issues10. Contribute to the development and update of RMPs in collaboration with MSL/GPSL, coordination with other functions11. Prepare responses to internal safety requests and contribute to responses to external safety queries12. Act as Subject Matter Expert (SME) for Medical Safety Expert Operations/ Medical Function (participation in initiatives).

Sheffield Hallam University

Master's degree

MRSVN

SSC

The English and Foreign Languages University, Hyderabad

Diploma

Osmania University

Bachelor's Degree