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Safety Manager
hace 2 meses
Thermo Fisher Scientific is seeking a highly skilled Safety Manager to coordinate safety responsibilities for one or more programs. The ideal candidate will have a strong background in safety management, regulatory compliance, and project coordination.
Key Responsibilities- Coordinate safety responsibilities for one or more programs, including staffing, training, and procedural compliance.
- Manage the safety team on respective programs, ensuring effective communication and collaboration.
- Develop and implement consistent internal processes and ensure compliance with established procedures.
- Liaise with senior management, project managers, and clients to ensure optimal performance and utilization of the safety project team.
- Manage multiple aspects of projects, including contractual, procedural, and regulatory requirements.
- Maintain good communication 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 stay updated on current regulations, practices, procedures, and proposals.
- Maintain a basic medical understanding of applicable therapeutic areas and disease states.
- Participate in on-call duties for specific projects and ensure 24-hour 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 lead departmental initiatives.
- Prepare and present proposals.
- Manage staff of experienced professionals, including interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching, and mentoring.
- 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 compliance with procedural documents.
- Strong knowledge of relevant therapeutic areas as required for processing adverse events.
- 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.
