Gitanjali Rawat
@gitanjalirawat
Pharmacovigilance Quality Lead improving ICSR quality through audits, coding expertise, and training.
IndiaWhat I'm looking for
I’m a pharmacovigilance professional with 10+ years of experience focused on end-to-end ICSR quality oversight, ensuring compliance with ICH E2B standards and client SOPs. As a Quality Lead, SME, and Trainer, I lead internal and retrospective quality checks, identify recurring error trends, and drive root cause analysis and CAPA planning.
I also serve as a go-to expert for complex cases, including SUSAR and Fatal/Life-Threatening events, and support case correction review, audit readiness, and inspection preparation. I enjoy building capability through structured training on Argus safety processes, MedDRA coding, safety narrative writing, and quality parameters—while tracking quality metrics, KPIs, and training effectiveness.
Experience
Work history, roles, and key accomplishments
Leads end-to-end quality oversight for pharmacovigilance case processing, ensuring compliance with ICH E2B standards and client SOPs. Serves as a pharmacovigilance SME and designs/trains teams on case processing workflows, coding, and quality standards.
Supports pharmacovigilance process quality through internal and retrospective quality checks and case correction activities. Provides day-to-day coaching/training support to ensure quality parameters are understood.
Assistant Professor
Devsthali Vidyapeeth
Jul 2019 - Oct 2020 (1 year 3 months)
Assistant Professor at Devsthali Vidyapeeth.
Performs quality review and processing of spontaneous, solicited, and E2B pharmacovigilance cases, including medical coding and safety narrative review. Handles case processing tasks such as completeness checks, report preparation, seriousness assessment, and database consistency verification.
Assistant Professor
GIS Institute of Professional Studies
Feb 2014 - Mar 2017 (3 years 1 month)
Assistant Professor at GIS Institute of Professional Studies.
Education
Degrees, certifications, and relevant coursework
GIS Institute of Professional Studies
Master of Pharmacy, Pharmaceutics
2011 - 2013
Grade: 76%
Completed M. Pharm in Pharmaceutics at GIS Institute of Professional Studies from 2011 to 2013, achieving 76%.
Hemwati Nandan Bahuguna Garhwal University
Bachelor of Pharmacy, Pharmacy
2007 - 2011
Grade: 66%
Completed B. Pharm at Hemwati Nandan Bahuguna University from 2007 to 2011, achieving 66%.
Availability
Location
IndiaAuthorized to work in
Job categories
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