Senior Safety Specialist

🔥 2 hours ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟠 Senior

✨ 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 2 hours ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Perform and potentially oversee day-to-day pharmacovigilance activities in a highly regulated environment • Collect, monitor, assess, evaluate, research, and track safety information • Collaborate with project team members, client contacts, investigators, adverse-event reporters, and third-party vendors • Work independently on daily pharmacovigilance activities • Participate in on-call duties for specific projects to provide 24-hour case-intake coverage from investigative sites • Lead activities and assist in developing program and departmental procedural documents • Prepare for and attend audits • Mentor less experienced staff • Review regulatory and pharmacovigilance publications and information sources • Maintain medical understanding of applicable therapeutic areas and disease states • Review cases for quality, consistency, and accuracy, including peer reports • Coordinate routine project implementation, including clinical trials and Endpoint Assessment Committee/Data Safety Monitoring Committee activities • Present at client and investigator meetings • Review project metrics and budget considerations

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of comparable experience • Equivalency may be met through a combination of appropriate education, training and/or directly related experience • Thorough understanding of pathophysiology and disease processes • Strong knowledge of relevant therapeutic areas for adverse-event processing • Excellent critical thinking and problem-solving skills, including appropriate evaluation and escalation • Proficiency in complex clinical study administration, including budgets and forecasting • Excellent oral and written communication and paraphrasing skills • Good command of English and ability to translate information into the local language where required • Computer literacy and ability to work within multiple databases • Proficiency in Microsoft Office, including Outlook, Word, and Excel • Thorough understanding of global regulatory requirements and compliance with procedural documents and regulations • Ability to manage and prioritize varied tasks and meet strict deadlines with limited supervision • Strong attention to detail • Ability to maintain a positive and professional demeanor in challenging circumstances • Ability to work effectively within a team to achieve shared goals

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Opportunity to contribute to patient safety and scientific excellence

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Senior Safety Specialist managing pharmacovigilance, safety case review, and clinical trial coordination for Thermo Fisher Scientific. Supporting patient safety across global pharmaceutical and biotech programs.

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