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KG Puneeth Kumar

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Enthusiastic M.Pharm (Pharmaceutics) student, holding a B.Pharm degree from Rajiv Gandhi University of Health Sciences,Karnataka. Possessing profound foundational knowledge in clinical data management, pharmacovigilance, and regulatory affairs, with key skills geared towards cultivating expertise in these domains. Clinical Trials: Comprehensive understanding of all phases of clinical Trials. Regulatory Compliance: Adherence to ICH-GCP Guidelines, 21 CFR Part 11, and principles of clinical research,Good documentation practices, regulatory compliance. CDM Fundamentals: Knowledgeable in essential documentation, including Start-up, Conduct, and Close-out phase , reconciliation, preclosure checks, edit checks, CDMP, EDC, CRF, and eCRF. Pharmacovigilance Basics: Familiarity with ICSR, Aggregate reporting, Signal management, Risk management, PSUR, Labelling, MedDRA, Med watch, WHODD, GCP, GVP, Pharmacology, and Drug classification. Possessing foundational/theoretical knowledge in Oracle Clinical,Medidata Rave,SAS (Statistical Analysis System),Argus Safety,OpenClinica Developing strong analytical capabilities for data accuracy. Effective communicator, ready for collaborative learning Passionate about leveraging academic knowledge to make a meaningful impact in the pharmaceutical/contract/clinical research organizations. Eager to explore opportunities for internships or entry-level roles to gain hands-on experience and contribute to the advancement of healthcare. Connect with me:Open to networking with professionals in the pharmaceutical and clinical research domain. Let's explore collaborative opportunities and contribute to the advancement of healthcare.

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