Senior Safety Reporting Specialist
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Job Description
Senior Safety Reporting Specialist leading compliant pharmacovigilance reporting for Thermo Fisher Scientific. Overseeing complex submissions, regulatory timelines, process improvements, and team mentoring.
Responsibilities:
- Lead and oversee preparation of complex safety reports
- Receive, prepare, and submit safety reports to applicable parties
- Ensure reports comply with regulatory timelines, country legislation, and agreed processes
- Monitor safety reporting compliance regularly
- Lead large-scale projects and ensure timely submission of safety reports
- Provide input and feedback for program and departmental procedural documents
- Share ideas and participate in implementing improvements
- Liaise with relevant departments and attend required meetings
- Provide guidance and feedback to team members
- Mentor new starters and assist lower-level colleagues
- Produce metrics and participate in financial projects
- Work in office, laboratory, and/or clinical environments with potential exposure to biological fluids and infectious organisms
- Use required personal protective equipment
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 5+ years
- Excellent knowledge of medical terminology
- Excellent Microsoft Office skills and good understanding of database functionality
- Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements
- Good time management and multi-tasking skills
- Strong attention to detail
- Ability to influence at all levels of the organization
- Ability to work well in a collaborative team environment
- Demonstrated initiative and persuasion and negotiation skills
- Excellent critical thinking and problem-solving abilities
- Ability to apply knowledge, skills, and expertise to assist lower-level colleagues in safety reporting activities
- Ability to work in an upright and/or stationary position for 6–8 hours per day
- Ability to perform frequent mobility, occasional crouching and stooping, and frequent bending and twisting
- Ability to lift and carry 15–20 lbs
- Ability to access and use in-house and off-the-shelf computer software
- Ability to communicate and understand spoken information and ideas
- Regular and consistent attendance
Benefits:
- Fully remote work arrangement
- Standard Monday–Friday work schedule
- Collaboration and professional development opportunities
- Mentoring and guidance opportunities
- Global team environment
- Personal protective equipment provided as required
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