Drug Safety Operations Manager/ Senior Level

at  Thermo Fisher Scientific

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.
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 overtim

Please refer the Job description for details