@saniakhan4
Drug Safety Associate-I at Parexel India, assessing ICSR reportability and coding adverse events with MedDRA.
IndiaAt Parexel International (India) Pvt Ltd, I triage and evaluate ICSR for completeness, accuracy, and regulatory reportability. I perform duplicate searches, code events with MedDRA, and review cases for causality and labelling.
At Tata Consultancy Services, Ltd, I trained and mentored associates in ICSR initiation, triaging, and processing, including specialized batches. I also supported case intake, follow-up, quality checks, and compliance activities.
Work history, roles, and key accomplishments
Maintains knowledge of adverse event safety profiles and global drug safety regulations. Triages and evaluates ICSRs for completeness, accuracy, and regulatory reportability, performing duplicate searches, MedDRA coding, and follow-up queries.
Trained and mentored associates on initiation, triaging, and processing of ICSRs including specialized batches. Developed agile mentoring plans, conducted sessions, provided feedback, and maintained documentation as part of the training team.
Oct 2019 - Nov 2020 (1 year 1 month)
Monitored incoming reports, triaged completeness and validity, and created cases on the safety database with accurate data capture. Performed MedDRA coding, causality assessment, follow-up, quality checks, and compliance activities including late case investigation.
Degrees, certifications, and relevant coursework
Master of Pharmacy, Pharmaceutics
Master's in Pharmacy with specialization in Pharmaceutics, completed in 2019.
Bachelor of Pharmacy, Pharmacy
Bachelor's in Pharmacy, completed in 2017.
Higher Secondary Certificate, Science and Commerce
Completed 12th standard in Science and Commerce in 2013.
Secondary School Certificate, General
Completed 10th standard in 2011.
Software and tools used professionally
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