工作职责:
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.
项目情况介绍：
1.国内知名药企肿瘤药临床II/III期项目
2.国内知名药企上市后产品
3.海外美国欧洲客户的信息基因药品国际多中心项目
任职资格:
1.医学、药学、流行病学、生物工程、化学相关专业，英语、日语等跟医药完全无关的专业不考虑
工作背景要求：
1. 具备至少2年及以上PV药物安全经验优先，
2. 纯上市前PV或者纯上市后PV经验
3. 对过往涉及的适应症及临床试验期数没有要求