Drug Safety Supervisor药物安全主管(J)

职位类别： 环境/健康/安全经理/主管

工作职责:

1. Achieves successful delivery of safety management services meeting internal and external client needs.

 Serves as the primary client liaison for drug safety management issues.

 Tracks compliance, tasks, resources, and overall budget for all assigned projects.

 Ensures timely completion of all project status reporting.

 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.

 Guides project team resources with assistance from functional management.

 Provides specific training as appropriate.

 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.

 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.

 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.

 Drug safety processes and best practices

 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.

任职资格:

1. Substantial clinical research experience required including minimum of 3-5 years’ experience in drug safety or in a similar field or experience in Project Management of 2-3 years minimum, preferably in drug/device development or clinical research.

2. Experiences in leading professional staff in a clinical research environment required with proven ability to oversee, mentor and effectively manage co-workers.

3. Skills with industry standard safety or clinical data bases is preferred.

4. Prior experience in the contract research environment is preferred.

5. Thorough knowledge of ICH GCP, GVP and Greater China regulatory authority drug development regulations is required

6. Read, write, and speak fluent English and Mandarin is required.

• 年龄要求： 不限
• 语言要求：不限