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panchkula, india
It's currently 2:56 AM here
Joined February 6, 2019
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Dr. Rumi B.
@DrRumiBhatia
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panchkula, india
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Physician, Medical Writing, PV consultant, Author
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Experience
Team Manager
Sep 2021 - Apr 2022 (7 months, 1 day)
o Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products.
o Documenting ad hoc health authority requests
o Experienced in signal management process including signal detection, Signal
tracking, signal documentation, signal evaluation reports (SERs) and ongoing safety surveillance activities.
Drug Safety Physician
Dec 2013 - Aug 2015 (1 year, 8 months)
o Provide medical safety assessment about additions/revisions to safety information contained in the Company Core Data Sheet and local labels
o Ensuring the quality, accuracy, timely review, overall medical assessment and validity/invalidity of literature reports.
o Experienced in reviewing and analyzing search results for signal detection.
o Performing review of full literature articles for Non-Case Reports (NCR) as per the validity criteria for signal detection.
Senior Drug Safety Physician
Dec 2013 - Aug 2015 (1 year, 8 months)
in partnership with Sanofi-Aventis, Experienced in Medical Review of (ICSRs) cases, for both literature and non-literature cases; along with providing medical inputs to concerned users., Experience in carrying out the review of Designated medical events (DMEs) and events of special interest;Medical review of SAE/CSR narratives, Experienced in authoring regulatory/safety reports for various therapeutic areas, Expertise in handling various safety &
Education
Project Management
(Less than a year)
LLB
(2 years)
MBBS
(7 years)
Qualifications
ACLS & BLS Certified Provider from AHA
American Heart Association
2022
ACLS & BLS Certified Provider from AHA
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
Harvard
2020
Certification in Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
Signal Detection and Assessment
Uppsala Monitoring, WHO
2021
Certification in Signal Detection and Assessment
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