Job title: Drug Safety Associate
Company: Golden Opportunities Private Limited
Job description: Description Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in the DS&E tracking tool and/or safety database. Ensure scientific
Description Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, create case file and initialize received drug safety reports in the DS&E tracking tool and/or safety database. Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality. Evaluate and finish processing of non-expeditable AE reports, including review for completeness and accuracy. Use medical dictionaries and business guidances to code medical history, drugs and adverse event terms. Prepare narratives summarizing the essential details of the case. Identify clinically relevant information missing from case report and facilitate its collection (in consultation with medical staff as required) by preparing follow-up request as needed. Alert manager to potential safety signals based on incoming case reports. Work with Novartis country safety departments, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and databased. Assist with related administrative and procedural activities as required or requested. Assists in the training of other Safety Processing Experts as necessary. Support DS&E Projects or database validation activities as required. EXPERIENCE (Must to have skills): Familiarity with medical terminology. Ability to learn quickly Ability to write clearly and concisely Analytical and logical thinking. High degree of accuracy and attention to detail. Ability to follow guidelines and enter large quantities of data with high degree of quality. Self-motivation and proactive stance to work Sense of urgency and commitment for timely completion of activities Prior Medical Transcription or Medical Writing experience preferred Previous safety or clinical trial experience desirable, but not essential Previous data entry experience desirable, but not essential
Location: Bangalore, Karnataka
Job date: Sun, 09 Jan 2022 23:19:32 GMT
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