崗位職責(zé):

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(xiàng)目情況介紹：

1.國(guó)內(nèi)知名藥企腫瘤藥臨床II/III期項(xiàng)目

2.國(guó)內(nèi)知名藥企上市后產(chǎn)品

3.海外美國(guó)歐洲客戶的信息基因藥品國(guó)際多中心項(xiàng)目

任職要求:

1.醫(yī)學(xué)、藥學(xué)、流行病學(xué)、生物工程、化學(xué)相關(guān)專業(yè)，英語(yǔ)、日語(yǔ)等跟醫(yī)藥完全無(wú)關(guān)的專業(yè)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(jīng)驗(yàn)優(yōu)先，

2. 純上市前PV或者純上市后PV經(jīng)驗(yàn)

3. 對(duì)過(guò)往涉及的適應(yīng)癥及臨床試驗(yàn)期數(shù)沒(méi)有要求