Safety Reporting Specialist
hace 4 semanas
Work Schedule and Environmental Conditions
Standard (Mon-Fri) in an office setting.
Job Description and Responsibilities
At Thermo Fisher Scientific, you will be part of a team that enables our customers to make the world healthier, cleaner, and safer. As a Safety Reporting Specialist, you will play a crucial role in bringing our Mission to life by ensuring the safety profile of new drugs in clinical trials is accurately reported.
Key Responsibilities:
- Receives, prepares, and submits safety reports to applicable parties, ensuring compliance with regulatory timelines and country legislation.
- Assists in producing metrics and alerts the manager to any quality or timeline issues.
- Participates on project teams, may lead projects of small to moderate scope, and provides training and support to other team members.
- Liaises with various departments around safety reporting tasks and the setting up of client accounts.
- Participates in audits where required and performs testing activities as needed.
Requirements:
- Bachelor's degree.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
- Strong knowledge of medical terminology, good written and verbal communication skills, and good Microsoft Word and Excel skills.
- 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.
Our Mission
We enable our customers to make the world healthier, cleaner, and safer. Our team of 100,000+ colleagues shares a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
Apply Today
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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