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Job Description
ClinChoice is seeking a Senior Executive/Specialist - Case Processing to join their team in Bengaluru. This role involves managing Individual Case Safety Reports (ICSRs) from intake to finalization, ensuring accuracy and adherence to regulatory timelines. The Senior Executive/Specialist will work with various source documents, perform data entry, and conduct quality reviews. They will also contribute to training, knowledge sharing, and compliance with PIMS and GDPR requirements.
Responsibilities:
- Perform duplicate search, intake, and triage of the received source documents.
- Perform data entry which includes but not limited to causality, labeling and seriousness assessments, MedDRA coding for all the events, medical history, and laboratory findings, and drafting narratives.
- Raise follow-up queries, as necessary, with appropriate documentation in the safety database or per applicable procedures within defined timelines.
- Perform quality review as applicable, of triage and data entry steps.
- Complete all assigned training, both internal and client initiated, within specified due dates.
Requirements:
- Master’s in science or above.
- Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream.
- Experience working in Argus safety database for Post Marketing, Literature, Investigator Sponsored Research, and Clinical Trials.
- Sound knowledge of Microsoft Office, specifically work in Excel.
Role Offers:
- Opportunity to work with a global company.
- Chance to contribute to patient safety.
- Professional development through training and knowledge sharing.
