Safety Manager
hace 1 semana
Thermo Fisher Scientific is seeking a highly skilled and experienced Safety Manager to join our team. As a key member of our organization, you will be responsible for coordinating contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance.
Key Responsibilities- Manage multiple aspects of projects, both local and globally, such as contractual, procedural, and regulatory requirements.
- Maintain good communications with other functional groups concerning program and company issues.
- Collaborate with other employees in problem-solving and systems improvement.
- Review regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures, and proposals.
- Maintain a basic medical understanding of applicable therapeutic area and disease states.
- May participate in on-call duties for specific projects and ensure 24-hr coverage for intake of cases from investigative sites.
- Provide plans and accurate forecasts for all projects.
- Serve as a resource to other departmental managers and leads departmental initiatives.
- Prepare and present proposals.
- Manage 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.
- Approve courses of action on salary administration, hiring, corrective action, and terminations.
- Review and approve time records, expense reports, requests for leave, and overtime.
- 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.
- 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.
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