Satish Jagdale
Safety Surveillance Physician @Tata Consultancy Services
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WORK HISTORY
Safety Surveillance Physician @Tata Consultancy Services
To develop and maintain safety signal detection strategy for assigned products. To identify safety signals from routine review of cumulative safety data and conduct initial evaluation of those signals and document outcome according to client specified criteria and requirements. To review and assess literature bulletins and published meeting abstracts in accordance with client’s search strategy, using relevant IS systems. To notify client side surveillance team of any safety signal that has been detected which may require urgent evaluation and action. To conduct further evaluation of safety signal as required by client, using client’s safety designated database and or the published literature. To prepare, summarize, evaluate and document routine Pre-SERM (Safety Evaluation Review Meeting) safety outputs from client’s dedicated safety database, dedicated external databases (FDA AERS, WHO Vigibase, Eudravigilance) and the published literature. To provide safety contribution to periodic aggregate reports (PSUR, PBRER, PAER/PADER, DSUR etc). To prepare Medical evaluations - Health hazard evaluation (HHE) or medical opinion memo (MOM) to support product quality issue investigations. To prepare response to questions raised by Health authorities. To participate in routine and ad-hoc team and project related meetings between client and TCS like Handover Meeting, Surveillance Meeting, and Safety Management Team Meeting. To prepare training material, conduct and assess periodic and need based trainings as and when required. To provide ongoing training on the updated surveillance strategy document, routine signal management requirements, product safety profiles and updated safety signal detection criteria for new hires.
EDUCATION
Government Medical College,Miraj
M.B.B.S;
SKILLS
ABOUT SATISH JAGDALE
Safety Surveillance Physician (Empirica Signal detection & management) at Tata Consultancy Services
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