Job Description

　　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.

　　Essential Functions

　　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, 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.

　　Education and Experience:

　　Bachelor's degree or equivalent and relevant formal academic/vocational qualification to include 3+ years of safety experience Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to

　　5+ years).

　　1+ year of leadership responsibility

　　In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

　　Knowledge, Skills and Abilities:

　　Working knowledge of the global regulatory requirements and the importance of and compliance with procedural documents

　　Strong knowledge of relevant therapeutic areas as required for processing AEs

　　General knowledge of pathophysiology and the disease process

　　Time management and project management skills

　　Proficient in Microsoft Office products and safety databases

　　Good command of English and ability to translate information into local language where required

　　Excellent oral and written communication skills

　　Strong attention to detail and accuracy

　　Strong critical thinking, problem solving and decision making skills