Receive, follow-up and report adverse events
- Review and process adverse events reported by Investigators
- Prepare Safety report as per Schedule-Y format to be reported to regulatory authorities and also other Investigators, who are part of the study
- Research and provide medical and scientific information to health care professionals and to various functional areas within the company
- Conduct and analyze, medical and scientific literature searches using critical judgment and professional / scientific expertise to support projects or queries
- Review clinical trial protocols, bioequivalence study protocols and provide inputs, support the clinical trial team
- Generates concise, accurate and well-written case narratives
- Responsible for effective and efficient development of the safety management plan, including development of specific processes to assure consistency within the project
- Effectively maintains the safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process
- Performs consistent coding of diseases, adverse events, and medication according to the project-specific coding conventions
- Supports the generation of Annual Safety Updates, Periodic Safety Reports, and other cumulative safety reports including data retrieval, analyses and quality control
- Reconciles SAEs in accordance with project specific guidelines
- Represents team at client meetings; contributes presentation of safety process at investigator meetings
source:http://www.clinicalresearchsociety.org/forum/pharmacovigilance/what-is-the-resposibility-of-drug-safety-associate/
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