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pv藥物警戒專員

8000-10000元
  • 武漢江夏區
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

不良事件藥品警戒
崗位職責:
In addition to the above:
1. Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.
2. Quality controls the reportability assessment of ICSR.
3. Conducts literature surveillance in the selected database(s) as outlined in the project scope of work and as per established procedures; forwards the information to the Medical Director for review and processes received information in accordance with project specific instructions.
4. Responsible for effective and efficient development of the safety section of the Safety and Medical Management Plan, including development of specific processes to assure consistency within the project.
5. Supports creation of the SAE/AE reconciliation plan and conducts SAE reconciliation in accordance with this plan and other project specific guidelines.
6. Supports analysis and quality control during the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports).
7. Supports signal detection and risk management activities.
8. Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.
9. Participates in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings.
10. Serves as Lead Drug Safety Associate and coordinates small regional teams of drug safety associates and safety data coordinators on project level (not more than three individuals), serves as the drug safety point of contact for study teams on project level.
11. Reports project status (including monthly metrics) to project/functional management within agreed upon timelines.
12. Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.
13. Proposes solutions for procedural and technical issues.
項目情況介紹：
1.國內知名藥企腫瘤藥臨床II/III期項目
2.國內知名藥企上市后產品
3.海外美國歐洲客戶的信息基因藥品國際多中心項目
任職要求:
1.醫學、藥學、流行病學、生物工程、化學相關專業，英語、日語等跟醫藥完全無關的專業不考慮
工作背景要求：
1.具備至少2年及以上PV藥物安全經驗優先，
2. 純上市前PV或者純上市后PV經驗
3. 對過往涉及的適應癥及臨床試驗期數沒有要求

工作地點

武漢江夏區華新大廈A幢16樓

職位發布者

顧意蓉/高級人力資源專員

三日內活躍
立即溝通
公司Logo上海康德弘翼醫學臨床研究有限公司
康德弘翼（WuXi Clinical），是藥明康德（WuXi AppTec）的一家全資子公司。始終致力為全球客戶提供全方位的臨床研究服務，包括藥品、生物制品、醫療器械、體外診斷試劑等醫藥產品，涵蓋BE(Bioequivalence)/ I期至IV期的臨床試驗。通過嚴格的質量控制體系和專業團隊的豐富經驗，幫助創新性，突破性醫藥產品盡快上市和造福患者。康德弘翼立足中國，面向世界，以上海總部為中心，輻射全球制藥公司、生物技術公司以及醫療器械公司。目前，公司實行全球聯合運營，人員規模達850+人，運營能力覆蓋中國、美國及澳大利亞等，并在上海、北京、廣州、武漢、成都、長沙、西安、沈陽、中國臺北、美國奧斯汀、美國圣地亞哥和澳大利亞悉尼等地均設有辦公室。公司團隊與各研究中心建立了良好的合作關系，始終保持著緊密的業務交流，保證了項目能高效、高質地完成。隨著業務能力和業務范圍的不斷拓展，康德弘翼進一步完善和增強了全球一體化研發服務平臺的綜合實力，助力全球創新合作伙伴更好、更快地開發醫藥產品。
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