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更新于 7月5日

PV Specialist (MJ001253)

8000-10000元
  • 沈陽沈河區(qū)
  • 惠工
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

藥品警戒不良事件臨床數(shù)據(jù)整理臨床試驗安全臨床研究
Primary Responsibilities: 1. Responsible for ensuring global regulatory reporting compliance by execution of processes and compliance with procedures for processing safety reports originating from clinical studies, literature, hotline, regulatory feedback data, social media and/or other sources for post-marketing products. 2. Identifying and capturing accurately the relevant information of ICSRs (Including serious and non-serious cases from unsolicited and solicited origin; and literature cases, as required) in safety database in accordance with ClinChoice and/or client conventions/guidelines, SOPs and liaising with the client if applicable. 3. Responsible for medical coding with MedDRA, WHODrug or other dictionaries, and narrative writing and safety review if applicable. 4. Ensuring the timely completion and distribution of AE/SAE/SUSAR/ADR/SADR reports to Health Authorities, client and/or client’s business partners etc.. 5. Ensuring timely identification of Individual Case Safety Reports and/or relevant safety information during the monitoring of the literature. 6. Maintaining a basic working knowledge of the adverse event safety profile of assigned drugs and labeling documents or IB. 7. Requesting additional information from the appropriate sender (investigators, medical representatives etc.), as required. 8. Supporting safety database creation and maintenance if applicable. 9. Supporting documents archiving in the filing system. 10. Other ad-hoc tasks assigned by PV leadership team. Qualifications: 1. Degree in life sciences or a prior experience in PV would be desirable. 2. The minimum qualification required would be a college/bachelor degree. 3. Basic conversational skills in English required. 4. Computer proficiency, an ability to work with web-based applications, and familiarity with the Windows Professional Operating System and the MS office suite (MS Word/Excel/PowerPoint). 5. Demonstrate understanding of SOPs and relevant regulations (e.g. ICH/GCP, NMPA, EMA, FDA and E2A to E2F etc.. 6. Experience in processing safety data within Argus preferred.

工作地點

沈河區(qū)沈陽財富中心-E座29層

職位發(fā)布者

王先生/HR

三日內(nèi)活躍
立即溝通
公司Logo昆翎(北京)醫(yī)藥科技發(fā)展有限公司
昆翎(ClinChoice)是一家致力于為生物醫(yī)藥和醫(yī)療器械客戶提供高品質(zhì)一站式服務(wù)的臨床階段CRO,服務(wù)包括臨床運營、項目管理、生物統(tǒng)計、數(shù)據(jù)管理、注冊事務(wù)、醫(yī)學(xué)事務(wù)和藥物警戒。昆翎已經(jīng)在中國、美國、歐洲、印度、日本和菲律賓建立了主要的臨床交付中心,目前在全球擁有1800多名員工,其臨床運營團隊覆蓋了亞、歐、北美等七個國家和地區(qū)。高盛直投部董事總經(jīng)理、昆翎董事會成員許小鷗先生認(rèn)為,“隨著創(chuàng)新療法在全球的增長,CRO公司提供高效、可靠的研發(fā)服務(wù)能力變得尤其重要。昆翎獨特的價值主張結(jié)合了其對于本地市場的了解、國際藥物研發(fā)的經(jīng)驗以及高效的團隊執(zhí)行能力。我們堅信公司強勁的管理層團隊以及其高效的執(zhí)行能力,將為昆翎的發(fā)展開啟新的篇章。
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