Safety Reporting Specialist

🔥 10 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Safety Specialist

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 10 minutes ago

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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

• 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 lead projects of small to moderate scope • Provide training and support to team members • File and maintain safety reporting systems and information • Liaise with departments on safety reporting tasks and client account setup • Participate in audits and perform testing activities • Share ideas and suggestions and participate in process improvement initiatives • Manage and coordinate regulatory and safety report production • Ensure accurate and timely adverse-event documentation • Support compliance with global pharmacovigilance requirements

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 2+ years • Equivalency may consist of a combination of appropriate education, training and/or directly related experience • 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 levels of the organization • Strong critical-thinking and problem-solving skills • Ability to work in an office/laboratory and/or clinical environment • Ability to work upright and/or stationary for 6–8 hours per day • Ability to perform repetitive hand movements and frequent mobility • Ability to crouch, stoop, bend, and twist • 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

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Opportunity to contribute to scientific excellence and breakthrough work

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