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[交流]
上海 药物警戒专员--PV
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PURPOSE Review, assess and process safety data received from various sources and distribute reports/data onwards to customers, regulatory authorities, endpoint adjudication committees or marketing authorisation holders. Work with Clinical Event Validation and Adjudication Services (CEVA) lead or CEVA management to coordinate and implement CEVA processes. RESPONSIBILITIES • Process clinical trial safety data by triaging initial and updated safety data, reviewing safety/CEVA data for inconsistencies, contacting sites with queries as needed, ensuring safety/CEVA data is corrected by site staff, ensuring translation of safety/CEVA data, entering applicable safety data into a serious adverse event (SAE) database when needed; writing narratives; coding terms, as appropriate; ensuring initial reports are sent to customers or marketing authorization holders within agreed timelines; updating narratives when updated information is received, as appropriate; liaising with customer/marketing authorization holders, executing case closure, reconciliation and preparation of events for archiving. • Process post-marketing safety data by receiving SAE and adverse event (AE) reports from various sources; identifying SAEs and AEs from literature sources; identifying brand of suspect product following receipt of report; identifying reporting sources; and assessing reportability and expectedness of events. • Process regulatory safety data by assessing SAEs and advising the department on SAEs that qualify as expedited regulatory reports; advising team members on timelines, procedures and format to adopt for reporting to regulatory authorities; advising team members on changes in SAE regulatory reporting requirements in different countries; reporting SAEs to regulatory authorities when appropriate; liaising with local Quintiles offices to facilitate expedited reporting; liaising with safety lead and systems manager for regulatory tracking requirements; and maintaining and updating regulatory safety database. • Process Clinical Event Validation and Adjudication cases in one or more of the following processes: Endpoint Adjudication Committee coordination, core laboratory coordination, and/or DMC administration and Steering Committee administration Job duties in this area include endpoint process design, including development of endpoint-related training, work flows and process documents; identification of endpoints for adjudication; ensuring (in conjunction with team members) that all required materials in support of an endpoint are obtained from the patient chart and prepared for submission; entering CEVA data into a tracking database as appropriate; management of endpoint and adjudication data, including tracking and reconciliation with Clinical Data Management; preparation and submit endpoint dossiers for adjudication; informing senior team members of progress toward endpoint objectives and any potential rate-limiting factors; and ensuring that for each reported endpoint in the clinical database, there is a matching, final endpoint adjudication.[ 来自版块群 上海 ] |
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2017-08-22 17:26:48, 37.07 K
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