Job Description
Summarized Purpose:
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
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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.
Qualifications:
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
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