Thermo Fisher Scientific · 13 hours ago
Drug Safety Operations Manager/ Senior Level
NC
Full-time
Remote
Senior Level
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Responsibilities
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 overtime.
Qualification
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Required
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 overtime.
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
Founded in 1956
10,001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (173)
2022 (314)
2021 (349)
2020 (251)
Funding
Current Stage
Public CompanyTotal Funding
$11.05BKey Investors
National Grid
2023-08-07Post Ipo Debt· $2.95B
2023-03-27Grant· $0.5M
2022-11-15Post Ipo Debt· $1.29B
Leadership Team
Daniella Cramp
Senior Vice President and President
Frederick Lowery
Senior Vice President Thermo Fisher and President Customer Channels
Recent News
2024-11-17
2024-11-15
Company data provided by crunchbase
