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sneha km

@snehakm

Pharmacovigilance Operations Specialist at IQVIA processing safety cases and supporting regulatory submissions.

India
Message

At IQVIA, I monitor and process incoming safety reports, from intake and triage through case processing and reconciliation. I work with clinical trial, post-marketing, literature, legal, and postbox cases.

I prepare MedDRA coding and case narratives, conduct literature screening, and support regulatory submissions and safety documentation. I also review patient eCRF data in Medidata and Inform to support adverse event reconciliation.

At AZIDUS LABORATORIES, I supported bioavailability study activities for Lacosamide extended-release tablets and assisted with clinical documentation and study records. I also support onboarding, training, and process guidance for junior team members at IQVIA.

Experience

Work history, roles, and key accomplishments

IQVIA logoIQ
Current

Operations Specialist 1

Sep 2019 - Present (7 years 2 months)

Monitor and process incoming safety reports from multiple sources, ensuring accurate and timely intake, triage, book-in, and reconciliation of pharmacovigilance cases. Perform data entry, case creation, case processing, MedDRA coding, narrative preparation, follow-up activities, and case documentation within safety databases.

Education

Degrees, certifications, and relevant coursework

Chettinad Academy of Research and Education logoCE

Chettinad Academy of Research and Education

Master of Science, Clinical Research and Experimental Medicine

2017 - 2019

Master of Science in Clinical Research and Experimental Medicine from Chettinad Academy of Research and Education, Chennai, from 2017 to 2019.

LC

Little Flower College

Bachelor of Science, Zoology

2014 - 2017

Bachelor of Science in Zoology from Little Flower College, Kerala, from 2014 to 2017.

Tech stack

Software and tools used professionally

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