Sandeep Kumar Gunapu
Associate Medical Director (Safety Evalaution & Risk Management) @GSK
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WORK HISTORY
Associate Medical Director (Safety Evalaution & Risk Management) @GSK
London, GB
EDUCATION
NTR University of Health Sciences
Bachelor of Medicine, Bachelor of Surgery - MBBS, Medicine
ABOUT SANDEEP KUMAR GUNAPU
An experienced Drug safety physician, seeking a secure position at a well-established organization that will lead to a lasting relationship in the field of drug safety/Pharmacovigilance/Clinical research that will enable me to use my strong assessment skills, educational background and ability to work towards professional growth and developmentIn-depth knowledge of Medical assessment of ICSRs, Risk Benefit Analysis, Analysis of aggregate safety data, Authoring sections of PEBRERs & RMP, PADER, AOSE, Signal Detection, Safety assessment for product alerts, Literature analysis, Signal risk management, Update of Core data sheets, SOP review, Training and Development, Health Hazard Assessments reports, Product quality complaint evaluation, Due diligence, Reg intel, MedDRA, Regulatory Authorities, Data entry, Medical Triaging, Narrative writing, Company comment section, SUSARs, Causality assessment, labelling, RSIs, IBs, etc and WHO-DD coding.Well-versed with ICH-GCP guidelines, GVP.Skilled in using drug safety database ARISg, ARGUS, MedDRA and WHO-DD coding, expedited reporting of SUSAR casesStrong knowledge in reporting regulations, different phases of clinical trials, Assessment of clinical data.Strong post-marketing and investigational event assessment, review and summarizing the data case narration.
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