Uma K.
Sr. Pharmacovigilance Specialist| Drug Safety Associate| Drug Safety Specialist| Safety Scientist| Case Processing| Narrative Writing| SAE Reconciliation| Quality review| Vendor Management| ICSR & Regulatory Submissions|
- Role
- Sr Pharmacovigilance Scientist at Daiichi Sankyo US
- Location
- Jersey City, NJ, US
- LinkedIn followers
- 500 followers
About Uma K.
Experienced healthcare professional with a medical degree and over 8 years of expertise…
Experience
Sr Pharmacovigilance Scientist
Aug 2023 — Present · NJ, US
Adept at providing MedDRA coding, Spontaneous cases and Post marketing surveillance case processing, overview of case processing, safety narrative and raise queries for the discrepancies in the source document when required.Ensuring the processing of cases with the most quality with productivity.Reviews medical and drug terminologies according to project specific coding conventions, package inserts, investigation brochure and company core data sheet.Ensuring perfection in any type of case while processing.Involved in the special projects whenever required like EV triage and others.Having knowledge of ICSR processing for all report types and in regulatory timelines.Reviewing the quality of the case and reporting the case to regulatory with at most quality within the timelines and reviewing the follow up for the caseAdept at providing MedDRA coding, Spontaneous cases and Post marketing surveillance case processing, EV and E2B case processing and even CIOMS processing, overview of case processing, safety narrative and raise queries for the discrepancies in the source document when required and following up the query.Having knowledge of WHO dug dictionary, and the company based medical dictionary.Setup report structures and populates model documents in CARA/PRISM. Runs Pre-Data lock listings, CIOMS, final listings and posts in CARA/PRISM.Activates the schedule for assigned Aggregate Report in pharmacovigilance Database System (Oracle Argus platform).Adds aggregate reports to Aggregate Reports Master Schedule (ARMS) tracker.Generation of PBRER and DSUR reports from LEAD Application as per ARMS.
Education
Jawaharlal Nehru Technological University
Bachelor of Pharmacy - BPharm
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