北京招聘

PURPOSE

Provides comprehensive safety services across the lifecycle of pharmaceutical compounds and medical devices, from first in human clinical trials through post-approval, marketed product, and regulatory safety requirements. Collects, tracks, and reports adverse events or clinical outcomes; analyzes and reports aggregate safety data; performs safety surveillance; and performs benefit-risk evaluation and planning.

Responsibily

? Implement and support operational decisions as determined and instructed by senior management. May contribute and assist in global initiatives e.g. Change Management

? SME Committees  and SOP Review Committees

? Retention, Engagement, training, processes etc.

? Assist in the implementation for measuring and improving employee engagement local and/or global actions. Maintain open and regular communication with direct reports to ensure a supportive working environment.

? Supervise Safety Operations staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work

? resolving problems and absence management. Approve actions on human resources matters.

? Support the management on project resource assignments, staff hiring and staff terminations in collaborations with operations specialist managers. - Assists with staff training

? Work closely with operations managers to address problem areas, work scheduling for current and projected projects, and projected peak workloads. Monitor, assess and report utilization of staff. Identify and implement solutions to address poor utilization.

? Ensure direct reports are cross trained on Safety service offering as applicable

? identify training and development needs of staff in collaboration with Training team and Safety Management.

? Lead and encourage direct reports in continuous improvement of department work processes, procedures and infrastructure. Instruct and lead direct reports in efficient management of project budgets through effective timesheet reporting. Work closely with operations specialist managers.

? Monitor and ensure that project processes and department deliverables meet expected quality, financial and productivity targets. Assist with meeting department utilization and realization targets.

? Ensure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, work instructions and client expectations.

? Ensure that staff have been trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Work Instructions and project instructions.

? Work with Safety Management constructively in a matrix framework to achieve project and customer deliverables.

? Effectively able to manage People issues

? Responsible for ensuring 100% compliance towards people practice and processes

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