工作职责:
1. Achieves successful delivery of safety management services meeting internal and external client needs.
61 Serves as the primary client liaison for drug safety management issues.
61 Tracks compliance, tasks, resources, and overall budget for all assigned projects.
61 Ensures timely completion of all project status reporting.
61 Serves as the primary contact for all assigned projects with project team members from Medical Monitoring, Data Management, Clinical Operations, Late Phase Services and Analysis and Reporting.
61 Guides project team resources with assistance from functional management.
61 Provides specific training as appropriate.
61 Coordinates and supervises typical Drug Safety Associate’s or Safety Data Coordinator’s tasks.
2. Ensures customer requirements are accurately captured and there is consistency across client’s projects.
61 Coordinates development of the project plan documents related to Safety and Risk Management services, e.g. Safety and Medical Management Plan, SAE Reconciliation Plan, and Coding Conventions.
61 Ensures quality control steps are properly planned, completed and documented on all projects.
3. Ensures that projects are delivered in accordance with all legal and contractual requirements.
4. Contributes to business development efforts for Safety & Risk Management.
5. Participates in initiatives for the implementation and integration of new or enhanced.
61 Drug safety processes and best practices
61 Drug safety systems, databases and tools
6. Provides technical guidance and mentorship for Drug Safety Associates or Safety Data Coordinators.
7. Develops and delivers training courses on Safety & Risk Management related topics to WuXi CDS’s employees within and outside Safety & Risk Management, as well as to external parties (investigators, clients).
8. Maintains an understanding of clinical research development, safety and risk management obligations during the entire product life cycle, safety processes and regulatory requirements.
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:
任职要求:
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3-5年PV药物安全经验，
2. 纯上市前PV或者纯上市后PV经验皆可
3. 对过往涉及的适应症及临床试验期数没有要求