Job Description

　　Summarized Purpose:

　　Manages the day-to-day operations of the safety program team. Supports staff members so that contracted safety services are provided in accordance with client and company policies and procedures. May interact with the client and internal groups to discuss and resolve issues impacting client operations. Trains and supervises healthcare and non-healthcare, professional level program staff. Develops, coaches, and mentor's staff. Develops consistent internal processes and ensures compliance with established processes.

　　Essential Functions and Other Job Information:

　　May supervise program staff performing pharmacovigilance data entry activities, utilizing medical/clinical background to participate in, manage, and conduct quality review of safety work.Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains a basic medical understanding of applicable therapeutic area and disease states. May participate in on-call duties for specific projects and ensures appropriate coverage for intake of safety cases.Oversees and/or completes development of client reports and procedural documents.Maintains thorough program knowledge, with an emphasis on medical/clinical content (where applicable), troubleshoots program issues, monitors and ensures compliance with company policies and procedures including SOP's, protocols, and other regulations by conducting quality monitoring of staff work.Acts as liaison between the client, program management and staff for operational issues such as workflow processes, available resources, and new initiatives impacting the program.Oversees all aspects of program training including conducting training, developing curriculum, and documenting and maintaining training records and curriculum.Acts as a resource for staff for assistance with managing their scope of service.May function as the front-line healthcare professional agent to cover services including but not limited to answering medical/clinical inquiries (where applicable) and documenting contacts, adverse events and product complaints.Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.

　　Policy & Strategy

　　Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units. Requires full knowledge of own area of functional responsibility.

　　Freedom to Act

　　Assignments are defined in terms of activities and objectives. Work is reviewed upon completion for adequacy in meeting objectives. A portion of the time may be spent performing individual tasks.

　　Liaison

　　Interacts frequently with internal personnel and outside representatives at various levels. Participates and presents at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues.