Senior Safety Specialist

🔥 17 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $75.8k - $126.3k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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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

• Perform day-to-day adverse event reporting and pharmacovigilance activities in a highly regulated environment • Receive, triage, manage, and reconcile adverse event reports, including scientific-literature reports • Collect, monitor, assess, evaluate, research, and track safety information • Coordinate adverse event data entry, coding, assessment, case review, follow-up, tracking, and regulatory reporting • Review cases and peer reports for quality, consistency, and accuracy • Prepare and maintain regulatory safety reports • Implement and coordinate routine projects, including clinical trials and Endpoint Assessment/Data Safety Monitoring Committees • Collaborate with project teams, clients, investigators, reporters, and third-party vendors • Interact with clients, healthcare professionals, clinical trial personnel, and consumers • Serve as a prime departmental contact on projects • Manage adverse events and endpoints, including complex medical-record review, adverse event narratives, MedDRA coding, and seriousness/listedness assessment • Work within multiple databases • Prepare for and attend audits, bid defenses, client meetings, and investigator meetings • Review metrics and budget considerations; provide budgetary oversight and escalate concerns • Participate in on-call duties to ensure 24-hour safety-reporting coverage • Review regulatory and pharmacovigilance publications to stay current • Lead and mentor a small unit or group; assign, review, and check work • Assist with program and departmental procedural documents • Complete project implementation, study maintenance, and closeout activities with minimal oversight • Work independently and escalate issues to management as needed

🎯 Requirements

• Bachelor’s degree in Pharmaceutical Science, Health Informatics, Biology, Nursing, or related field • Five (5) years of experience in the job offered or as a Safety Specialist, Research Associate, Medical Technologist, Pharmacist, or related role • Five (5) years of experience with Individual Case Safety Reporting or Drug coding software (ICSR) • Five (5) years of experience with computerized information systems and standard application software (Windows, MS Office) • Five (5) years of experience with pharmacovigilance safety reporting responsibilities, including SAE receipt and reporting to clients • Five (5) years of experience with therapeutic areas and processing SAEs and AESIs • Five (5) years of experience conducting and participating in PV-specific kick-off meetings and client meetings • Five (5) years of experience ensuring tasks align with contracted scope, Safety Management Plan requirements, and regulatory timelines • Five (5) years of experience identifying, reporting, and mitigating quality risks through Quality Events • One (1) year of experience with database user interface and query software, including Electronic Data Capture review and reconciliation • One (1) year of experience with project implementation, maintenance, and closeout activities