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B.Pharmacy graduate with a strong background in Clinical Research, Clinical Data Management, and Pharmacovigilance, complemented by training in ICH-GCP, GVP, ICH E2A-E2F, and ICSR processing. Proficient in narrative writing, CRF/eCRF review, and clinical trial documentation, demonstrating meticulous attention to detail and adherence to regulatory standards. Committed to enhancing data integrity and patient safety while supporting regulatory compliance in entry-level clinical research roles. Prepared to leverage academic knowledge and practical skills to contribute effectively to a dynamic research team.
Clinical Research: ICH-GCP Guidelines, Clinical Trial Phases (0–IV), Protocol & CSR, Ethics (IRB/IEC, Declaration of Helsinki, Belmont Report), Randomized Trial, Blinding, Biasness, Centralised/Decentralised Trials, IRT, CRA/CRC/ Sponsor/Investigator, TMF/e-TMF, Informed Consent (ICF), CRF, CFR Regulations
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