Kshama Mishra
Clinical Safety Associate @Recor Medical
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WORK HISTORY
Clinical Safety Associate @Recor Medical
Palo Alto, CA, US
Process clinical and commercial adverse events including timely review, assessment, coding (MedDRA), and reporting.• Collaborate with clinical site managers and research associates to ensure accurate review and reporting of adverse events.• Write detailed safety event narratives and prepare materials for DSMB and CEC.• Prepare safety data for annual, interim, and final clinical reports.• Support vigilance safety assessment and reporting per regulatory requirements.• Familiar with Marvin, Inform, Posit connect and Medidata Rave RCM databases.
EDUCATION
UC Berkeley Extension
Certificate program in Clinical research conduct and management
Ayush and Health Science University of Chattisgarh, Raipur
Bachelor of Medicine, Bachelor of Surgery - MBBS, Medicine
ABOUT KSHAMA MISHRA
Proficient in Oracle Argus Safety database including end to end case processing, triaging, quality control, submissions and coding using MedDRA.• Expert in causality assessment, writing case narratives, follow-up.• Handled serious and non-serious spontaneous, individual case safety reports (ICSRs), literature articles, and reports from licensing partners and regulatory authorities.• Seeking an opportunity to leverage my skills, knowledge, and experience with a progressive organization in the pharmaceutical industry.
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