Safety Reporting Specialist

• 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 potentially lead small- to moderate-scope projects
• Provide training and support to team members
• Maintain safety reporting systems and information, including filing
• Liaise with departments on safety reporting tasks and client account setup
• Participate in audits and perform testing activities as needed
• Share ideas and suggestions and participate in process improvement initiatives

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 2+ years of previous relevant experience
• Equivalent combination of appropriate education, training and/or directly related experience may be sufficient
• 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 organizational levels
• Strong critical thinking and problem-solving skills
• Ability to work in an upright and/or stationary position for 6–8 hours per day
• Ability to perform repetitive hand movements
• Frequent mobility; occasional crouching, stooping, bending, and twisting
• Ability to lift and carry 15–20 lbs
• Ability to use in-house and off-the-shelf computer software
• Ability to communicate and understand spoken and written information
• Ability to perform under stress and multitask
• Regular and consistent attendance

• Global team environment
• Collaboration and development opportunities
• Passion, innovation, and commitment to scientific excellence
• Opportunity to contribute to scientific breakthroughs