Safety Reporting Specialist

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Safety Specialist

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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

• 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 lead small- to moderate-scope projects • Provide training and support to team members • 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 • Ensure accurate and timely adverse-event documentation and support global pharmacovigilance compliance

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 2+ years • 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 • Regular and consistent attendance • Ability to work in an upright and/or stationary position for 6–8 hours per day • Ability to perform frequent mobility, bending, twisting, crouching, stooping, and light to moderate lifting up to 15–20 lbs • Ability to access and use computer software • Ability to communicate and understand spoken and written information • Ability to perform under stress and multitask

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Scientific excellence-focused workplace

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