Job Description

Work Schedule

Environmental Conditions

Coordinates contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Manages the safety team on respective programs. Works with senior

management, and develops consistent internal processes and ensures compliance with established

processes. Proactively liaises with the Project Manager (as appropriate) and clients and ensures optimal performance and utilization of the safety project team.

 Manages multiple aspects of projects, both local and globally, such as

contractual, procedural and regulatory requirements.

 Maintains good communications with other functional groups concerning

program and company issues. Collaborates with other employees in problem

solving and systems improvement.

 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

24-hr coverage for intake of cases from investigative sites.

 Provides plans and accurate forecasts for all projects.

 Serves as a resource to other departmental managers and leads departmental

initiatives.

 Prepares and presents proposals.

 Manages staff of experienced professionals, which may include interviewing and

selection, 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

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