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Resume CV : Clinical Research Associate CRA
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[QUOTE=Guest;216606]PRAJJUALMAKHAIK [B]Email [/B]: prajjvalkotgarh777 AT gmail.com [B]PROFILE [/B]: I am a motivated, adaptable professional with First class degree in Bachelor in Pharmacy and Pg Diploma in Clinical Trials Research & Administration seeking an opportunity in this field. I enjoy working on my own initiative or as part of a team and see myself as a reliable, trustworthy, hardworking and enthusiastic person. In short I have a genuine interest in working in Pharmacy co-vigilance & Clinical research. [B] PRACTICAL SKILLS [/B]: - Comprehensive knowledge of Adverse Events narration (AE) and guideline associated with narration of Adverse Events. - Plan, organize, and manage daily work to meet service level timelines and deliverable. - Skills to perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs). - Sound knowledge of Drug safety process. - Knowledge of handling submission of ICSR’s (Individual Case Safety Reports) and other reports for various regulatory authorities across the globe. - Knowledge of Single Case Processing (both Serious & Non serious cases). - Initial data entry of case reports into safety database / tracking system. - Prioritize the cases. - Knowledge of processing the adverse events received in SAE, CIOMS, and MED WATCH forms. - MEDRA coding for the events and the case narrative. - Knowledge of and ability to interpret and apply global safety regulations. - Comprehensive knowledge of Good Pharmacovigilance practices, GMP, GLP and GCP guidelines. - Proficient in using Microsoft Windows XP, Microsoft Office XP Professional. .= [B]EDUCATION & QUALIFICATIONS [/B]: Diploma in advanced Clinical Trials Research & Administration studies from BII, Noida in the year 2012. GCP Certificate from Biopharma Institute in the year 2012. Bpharma from Himachal Pradesh University scored 78% in the year 2012. [B] SKILLS [/B]: - Application of modern biological procedures to applied and fundamental research. - Team working skills. - Information handling and literature searching. - Oral and written communication skills.[/QUOTE]
