Ramesh Kambar Email & Phone Number

Mysuru Area, India

• Worked on ArisG database.• Quality review of spontaneous and clinical cases pushed into QC workflow.• Finalization and distribution of cases to different regulatory authorities as per there regulations.• Create new follow up of a case based on the new information received.• Determines necessary follow up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge

Mumbai Area, India

Worked on Oracle Argus Database. Perform accurate data entry of case including determination of seriousness criteria for event, coding of event, causality assessment of event with respect to drug, writing concise narrative of case and labeling of events. Ensures that all safety reports received from any source (clinical trials and post marketing)For assigned products and/or studies, are processed and reported according to ICH GCP guidelines, regulatory requirements and company SOPs, policies and procedures.