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Pharmacovigilance Professional Regulatory Affairs Associate
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Drug/Patient Safety Specialist
Tata Consultancy Services • Full time
Mar 2016 - Aug 2021 • 5 yrs 5 mos
Processed Serious Adverse Events (SAE) and non-serious reports using Argus Safety. Performed MedDRA and WHO-DD coding, evaluated causality and seriousness, and drafted clinical narratives. Conducted medical record extraction and assisted in training new associates while ensuring strict regulatory compliance and meeting quality benchmarks.