FSP Safety Reporting Specialist – Night Shift

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🔥 1 hour ago

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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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