Senior Safety Reporting Specialist
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Job Description
Senior safety reporting specialist overseeing compliant pharmacovigilance reports at Thermo Fisher Scientific. Leading safety-reporting projects and mentoring colleagues to protect patient health.
Responsibilities:
- Receive, prepare, and submit safety reports to applicable parties
- Ensure reports comply with regulatory timelines and country legislation
- Monitor safety-report compliance regularly
- Lead large-scale projects and ensure submissions follow agreed processes and regulatory timelines
- Provide input and feedback for program and departmental procedural documents
- Share ideas and suggestions and participate in their development and implementation
- Liaise with relevant departments on safety reporting tasks and attend required meetings
- Provide input, feedback, and guidance to team members
- Mentor new starters
- Produce metrics and participate in financial projects
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 5+ years
- Equivalent combination of appropriate education, training and/or directly related experience may be considered
- Excellent knowledge of medical terminology
- Excellent Microsoft Office skills and good understanding of database functionality
- Excellent knowledge of procedural documents and 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 assist lower-level colleagues in safety reporting activities
Benefits:
- Collaboration and development opportunities
- Opportunity to contribute to scientific excellence and patient health
- Work as part of a global team
- Standard Monday–Friday work schedule
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