Senior Safety Specialist

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

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👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Regularly monitor and manage GPS mailboxes • Communicate with safety vendors regarding individual case safety reports and aggregate reports/listings • Manage reviews of ICSRs, listings, tables, and figures for completeness and quality • Manage serious adverse event reconciliation across post-marketing and clinical trial databases and listings • Collaborate with clinical, medical, regulatory, healthcare professional, consumer, and contracted-resource stakeholders to obtain safety information • Participate in meetings and take minutes as required • Support generation of aggregate safety reports • Communicate with business partners and distributors regarding receipt and transmission of safety information under applicable data exchange agreements • Attend GPS operational meetings and contribute as a subject matter expert • Identify issues and improvement areas and escalate appropriately • Contribute to developing new processes and procedures • Support implementation of new processes and systems • Perform activities in compliance with client controlled procedures and applicable global and local regulations • Perform other tasks assigned by the line manager or Head of GPS

🎯 Requirements

• Fluent communication in written and spoken English • Advanced knowledge of medical terminology, pharmacovigilance processes, and relevant global regulations, including EU, US, and Japan requirements • Ability to communicate complex issues clearly and effectively • Ability to manage and prioritize tasks to meet deadlines • Ability to solve routine problems with limited supervision and raise issues constructively • Ability to deliver high-quality documents, including work instructions, guidelines, forms, and templates • Ability to manage timelines for deliverables with minimal support • Ability to make basic operational decisions while understanding impact and potential risk • Advanced computer skills, including Microsoft Office proficiency • Proficiency with safety database systems such as Argus or ArisG • Proficiency with MedDRA coding • Bachelor's or Master's degree, or local equivalent, in nursing, healthcare, life science, or a relevant field • 3–5 years of relevant experience in global pharmacovigilance/drug safety, including EU and US • Equivalent and adequate combination of education and experience • Solid experience with end-to-end safety event collection and reporting • Experience developing and submitting aggregate safety reports such as DSUR and PSUR • Solid expertise in global EU/US pharmacovigilance requirements and practices • Solid experience with safety database systems, including workflow management • Ability to communicate, receive, and understand information and ideas with diverse groups of people • Ability to work upright and stationary for typical working hours • Ability to use and learn standard office equipment and technology proficiently • Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities

🏖️ Benefits

• Health and wellbeing support • Healthy and balanced work environment • May require travel