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Omkar Kore

@omkarkore

Clinical research candidate with pharmacy training who analyzed reported ADRs and supported regulatory submissions at HLL Lifecare Limited.

India

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What I'm looking for

I’m seeking an entry-level position in clinical research where I can contribute to the development of new therapies, perform research tasks, and gain hands-on experience in clinical trial processes.

At HLL Lifecare Limited, I supported ONDLS submissions and dossier preparation, reviewed regulatory documents, and helped maintain audit documentation in the Unit Management Representative department. I also maintained Batch Manufacturing Records and supported R&D sample handling.

For my research project, I reviewed spontaneously reported adverse drug reactions, checked data for completeness, and conducted basic frequency profiling. My pharmacy studies also covered Good Clinical Practice, clinical data management, electronic data capture, and pharmacovigilance.

Experience

Work history, roles, and key accomplishments

Regulatory Affairs Trainee

HLL Lifecare Limited

Supported online submissions through ONDLS and dossier preparation. Reviewed regulatory documents for accuracy and completeness, and maintained documentation for manufacturing and distribution licences.

Regulatory Affairs ONDLS Dossier Preparation Document Review SOPs Compliance Audit Support Research Documentation BMR Quality Control (QC)

Industrial Trainee

S.G. Phyto Pharma Pvt. Ltd.

Gained exposure to manufacturing operations, QA/QC systems, cGMP, and regulated documentation. Supported routine quality checks, documentation review, and HPLC testing.

Manufacturing Operations QA&QC GMP Documentation HPLC Quality Checks