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更新于 8月29日
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北京-藥物警戒專員（Contract PV）

1-1.5萬
  • 北京朝陽區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招1人

雇員點評標(biāo)簽

  • 同事很nice
  • 工作環(huán)境好
  • 團隊執(zhí)行強
  • 人際關(guān)系好
  • 氛圍活躍
  • 管理人性化
  • 實力大公司
  • 交通便利

職位描述

器械警戒
崗位職責(zé):
1. Enters information into ICSR tracking sheet for receipt and submission of safety report.
2. Processes ICSRs according to Standard Operating Procedures (SOPs), Working Instructions (WIs) and safety
database user manual
? Receives and documents incoming safety report from all sources.
? Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.
? Enters data into safety database.
? Codes events, medical history, indications of medications, concomitant medications and tests.
? Compiles complete narrative summaries.
? Assesses information to be queried and follows up until information is obtained and queries are
satisfactorily resolved.
? Participates in the generation of timely, consistent and accurate reporting of expedited reports in
accordance with applicable regulatory requirements.
3. Completes distribution of all required individual expedited and periodic reports for both clinical and postmarketing products within required timeline.
4. Assists in the preparation of the Safety Management Plan.
5. Participates in audit/inspection as required.
6. Ensures all relevant documents are stored appropriately per company SOP.
7. Performs literature search and review.
8. Maintains understanding and compliance with SOPs, WIs, PV related global and local legislation and regulations, ICH guidelines.
9. Coordinates with data management staff concerning SAE reconciliation between the clinical and safety databases.
10. Liaises with partners and other stakeholders regarding safety data collection and reconciliation.
11. Completes other tasks assigned by line manager.
任職要求:
1. Bachelor’s degree or above in life science, medical, medicine or equivalent with minimum of 2 years of
pharmaceutical/biotechnology PV case processing experience, including clinical trial and post-marketing
experience.
2. Familiar with clinical trial process across Phase I-IV, PV related legislation and regulations, ICH guidelines.
3. Strong communication and presentation skill.
4. Able to work on multiple tasks and projects.
5. Detail oriented with high degree of accuracy.
6. Good time management skill and able to meet deadlines.
7. Fluent English in reading and writing, basic English in oral.
8. Experience in using safety database, e.g Argus, ArisG

工作地點

北京朝陽區(qū)建國門外大街20號聯(lián)合大廈808

職位發(fā)布者

程紅/招聘

剛剛活躍
立即溝通
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