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Safety Reporting Specialist
hace 2 meses
Thermo Fisher Scientific is seeking a highly skilled Safety Reporting Specialist to join our team. As a key member of our organization, you will be responsible for the receipt, submission, and tracking of expedited and periodic safety reports related to our projects.
Key Responsibilities- Receive, prepare, and submit safety reports to applicable parties, ensuring compliance with regulatory timelines and country legislation.
- Assist in producing project metrics and alert management to any quality or timeline issues.
- Participate in project teams and lead projects of small to moderate scope, providing training and support to other team members.
- Perform administrative tasks, including filing and maintaining safety reporting systems and information.
- Liaise with various departments on safety reporting tasks and client account setup.
- Participate in audits and perform testing activities as needed.
- Share ideas and suggestions with team members, ensuring effective communication and participating in process improvement initiatives.
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years).
- Strong knowledge of medical terminology.
- Good written and verbal communication skills.
- Good Microsoft Word and Excel skills and solid understanding of safety database functionality.
- Solid knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines).
- Ability to juggle multiple tasks while delivering high-quality results.
- Strong attention to detail and accuracy with an orientation toward careful and meticulous work.
- Possess the maturity to handle sensitive information and data effectively.
- Ability to interact effectively with all levels of the organization.
- Strong critical thinking and problem-solving skills.
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel.