FSP Safety Reporting Specialist – Night Shift
Posted 1hrs ago
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Job Description
Safety Reporting Specialist managing regulatory and safety reports for compliance with pharmacovigilance requirements. Ensuring accurate documentation and support for the global team in a fully remote role.
Responsibilities:
- Manage and coordinate the production of regulatory and safety reports
- Ensure accurate and timely documentation of adverse events
- Support compliance with global pharmacovigilance requirements
- Receive, prepare and submit safety reports to applicable parties
- Escalate to lead and/or line manager if any issues are encountered
- Ensure reports are submitted in compliance with regulatory timelines and country legislation
- Assist in producing metrics and alerts managers to any quality or timeline issues
- Participate in project teams and may lead projects of small to moderate scope
- Provide training and support for other team members
- Perform administrative tasks such as filing and the maintenance of safety reporting systems and information
- Liaise with various departments around safety reporting tasks and the setting up of client accounts
- Participate in audits where required and performing testing activities as needed
- Share ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives.
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).
- Strong knowledge of medical terminology
- Good written and verbal communication skills
- Good Microsoft Word and Excel skills and solid understanding of safety database functionality
- Solid knowledge of procedural documents and working knowledge of global safety reporting requirements (including FDA regulations and guidelines)
- Ability to juggle multiple tasks while still delivering high quality results
- Strong attention to detail and accuracy with orientation toward careful and meticulous work
- Possess the maturity to handle sensitive information and data effectively
- Ability to interact effectively with all levels of the organization
- Strong critical thinking and problem-solving skills.
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Professional development opportunities
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