Manager, Safety & PV/药物警戒经理

JOB SUMMARY Manages Safety team members responsible for all Safety services while adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, Good Pharmacovigilance Practices (GVP) and study procedures. Participates in process development, budget reviews, and project management. Ensures consistency and communication between the Safety team members and management. JOB RESPONSIBILITIES • Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization. • Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives. • Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with senior safety management. • Manages projects where Safety and Pharmacovigilance are the primary services. o Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed. o Works with Finance to ensure appropriate customer invoicing, where required. o Approves project time cards and invoicing. o Provides sponsors with scheduled project updates and reports. o Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues. • Participates in the management of the Safety and Pharmacovigilance department with the following actions: o Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) o Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan. o Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions. o Works with Business Development to actively solicit new business, as needed. o Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings. • Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance. Participates in bid defense meetings. Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form. Approves budget projections for the project. • Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process. • Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentor Safety team members • Managing resourcing's needs/issues and escalating to senior management as necessary. • Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions. • Performs other work related duties as assigned. • Minimal travel may be required. QUALIFICATION REQUIREMENTS • BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience • Progressive responsibility with demonstrated leadership skills and project management • Clinical Research Organization (CRO) experience with therapeutic specialties preferred • Working knowledge of financial budgets and various financial analysis tools preferred • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet • Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills • Ability to establish effective relationships with clients as well as team members • Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment • Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment