I'm a Quality Control Analyst by profession with my passion to start my career in Pharmacovigilance I am available as immediate joiner for Drug Safety Associate.I am fully equipped with relevant skills for the job of Drug Safety Associate and ability to work independently but guided by documented procedures, with appropriate support. My professional skills in Pharmacovigilance are:-Performing the review and evaluations of ICSR information for validity, seriousness, expectedness and causality assessment following standard Pharmacovigilance procedures and guidelines.-Hands on writing safety narratives forICSR from different sources like spontaneous, literature etc.-Good knowledge about safety database ICSR processing with defined WORKFLOW includingDuplicacy check , case Book-In, complete case entry.-Knowledge to perform MedDRA coding for medical history, events, drugs/procedures/indication and laboratory tests in ICSRs.-Exposure to Global pharmacovigilance activities and standards including ICH, GVP, 21 CFR, CIOMS etc. for development and/or marketed products.-Exposure to aggregate reporting in Pharmacovigilance including PSUR/PBRER, PADER, DSUR including processes, timelines and standards as per EU, ES etc.-Exposure to signal generation and safety analysis activities.In addition,I have excellent attention to details ability work effectively as part of a team if once given the opportunity will be a valuable asset to the organisation.
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Quality Control AnalystOcean Pharmacoat Pvt Ltd Jun 2022 - Dec 2022Hyderabad, Telangana, IndiaConduct tests to determine quality of raw materials, bulk intermediate and finished products. May conduct stability sample tests.
Frequently Asked Questions about Usha M
What is Usha M's role at the current company?
Usha M's current role is Actively seeking for job related to Pharmacovigilance,Clinical Data Management, Clinical Research, Medical Coding.
What schools did Usha M attend?
Usha M attended Narasaraopeta Institute Of Pharmaceutical Sciences, Kotappakonda Road, Yellamanda (P.o), Narasaraopet (Md) Pin- 522 601,(Cc-Cd).
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