Karishma Abigail Bose
Manager Safety Operations & Compliance at Cardiovascular Research Foundation
- Role
- Manager, Safety Operations & Compliance at Cardiovascular Research Foundation
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
About Karishma Abigail Bose
An experienced clinical research and healthcare professional with expertise in drug and device safety during clinical trials, the DSMB and CEC involvement in the device safety process, narrative writing for adverse events and primary endpoints for clinical medical device studies managed by the Cardiovascular Research Foundation. Also with expertise in coding using MedDRA. Proficient in developing and maintaining Device/Drug Safety Information (DSI) infrastructure, corrective action plans, reconciliation of drug safety databases and clinical study databases for adverse event reporting, monitoring timelines for event processing, reviewing summary of safety data at regular intervals, and monitoring adjudication results of the Clinical Events Committee {CEC) or Data Safety Monitoring Board (DSMB), and Medical Safety support in working with the FDA including 510(k) and Pre-Market Approval (PMA) submissions, responses to FDA questions, and preparation at FDA advisory panel.
Experience
Manager, Safety Operations & Compliance
Cardiovascular Research Foundation
Nov 2024 — Present · US
Education
Christian Medical College, Ludhiana, Punjab
Bachelor's degree, Medicine
2003 — 2008
Sollers College, Edison, New Jersey USA
Certificate, Advanced Drug Safety and Pharmacovigilance
2018 — 2018
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