KG Puneeth Kumar's Linkedin Analytics

Dedicated and detail-oriented B Pharm graduate currently pursuing M Pharm (Pharmaceutics) anticipating completion around October 2024. I am passionate about advancing my career in Pharmaceutical Regulatory Affairs/Clinical Data Management / Pharmacovigilance, or within Clinical Research Organizations. My strong foundation in pharmaceutics, regulatory affairs, and clinical research positions, helps me to make meaningful contributions in these fields". Key Strengths and Knowledge Areas: Clinical Trials: In-depth understanding of the drug discovery and development process, and comprehensive knowledge of all clinical trial phases. Possessing foundational knowledge in Clinical research (protocol, IRB, Inform conset form, ICSR etc..) Regulatory Affairs : Basic understanding in Pharmaceutical Regulatory Affairs, including GCP (Good Clinical Practice), 21 CFR Part 11, , CMC (Chemistry, Manufacturing, and Controls), CTD, knowledge about regulatory authorities, dossier,labeling requirements, and documentation etc.. Clinical Data Management (CDM): Proficient in essential CDM process,across start-up, conduct, and close-out phases,case report forms (CRF) and eCRF, and CTMS. Pharmacovigilance: Familiar with Pharmacovigilance process. Having essential knowledge in the following: ICH GCP Guidelines, ICSR, protocol, aggregate reporting, signal management, PSUR, MedDRA, MedWatch, , GCP, GVP, pharmacology, and drug classification etc.. Technical Proficiencies: Basic theoretical knowledge of Medidata Rave, Argus Safety, OpenClinica,Veeva Vault, RIMS. Utilized Microsoft Office applications in academic process ,possessing basic knowledge in the above. I am eager to apply my academic knowledge and skills in a professional setting, contributing to advancements in clinical research and regulatory processes. Open to internships or entry-level roles. I am enthusiastic about gaining hands-on experience and making a positive impact in the pharmaceutical and healthcare sectors.