Safety Reporting Specialist
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Job Description
Safety Reporting Specialist coordinating regulatory and adverse-event reports for Thermo Fisher Scientific, a global scientific services company. Supporting pharmacovigilance compliance, audits, safety systems, and process improvements.
Responsibilities:
- Manage and coordinate the production of regulatory and safety reports
- Receive, prepare, and submit safety reports to applicable parties
- Escalate issues to the lead and/or line manager
- Ensure reports comply with regulatory timelines and country legislation
- Produce metrics and alert managers to quality or timeline issues
- Participate in project teams and lead small- to moderate-scope projects
- Provide training and support to team members
- Maintain safety reporting systems and information
- Liaise with departments on safety reporting tasks and client account setup
- Participate in audits and perform testing activities
- Share ideas and suggestions and participate in process improvement initiatives
- Ensure accurate and timely adverse-event documentation and support global pharmacovigilance compliance
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 2+ years
- Strong knowledge of medical terminology
- Good written and verbal communication skills
- Good Microsoft Word and Excel skills
- Solid understanding of safety database functionality
- Solid knowledge of procedural documents
- Working knowledge of global safety reporting requirements, including FDA regulations and guidelines
- Ability to manage multiple tasks while delivering high-quality results
- Strong attention to detail and accuracy
- Ability to handle sensitive information and data effectively
- Ability to interact effectively with all levels of the organization
- Strong critical thinking and problem-solving skills
- Regular and consistent attendance
- Ability to work in an upright and/or stationary position for 6–8 hours per day
- Ability to perform frequent mobility, bending, twisting, crouching, stooping, and light to moderate lifting up to 15–20 lbs
- Ability to access and use computer software
- Ability to communicate and understand spoken and written information
- Ability to perform under stress and multitask
Benefits:
- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused workplace
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