Drug Safety Reporting Coordinator

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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

• Provide administrative safety support to the Pharmacovigilance department • Submit expedited and periodic safety reports to applicable parties • Scan, index, file, archive, and quality-check safety reports in electronic and paper systems • Complete safety trackers and resolve simple submission-pack problems • Liaise with teams and departments on administrative safety reporting tasks • Support audit readiness, meeting organization, minute taking, work distribution, report reconciliation, metrics, and system updates • Extract and collate reporting information via the Clinical Trial Management System • Maintain and update contact lists in organizational systems • Support department and Pharmacovigilance initiatives • Train Pharmacovigilance staff on safety reporting processes and associated systems • Provide filing support, barcode safety reports, identify inaccuracies, and maintain file-room cleanliness and organization • Assist with file reviews, audit notifications, file-return notifications, and on-site audits when required • Coordinate study files and inventories for clients, including external postal distribution • May mentor or train new central safety reporting administrative staff

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Technical positions may require a certificate • At least 2 years of previous experience providing relevant knowledge, skills, and abilities • Equivalency may be met through a combination of appropriate education, training, and/or directly related experience • Effective teamwork and ability to support assigned leads and line managers • Proficiency in Microsoft Office Programs: Word, Excel, PowerPoint, and Access • Solid knowledge of procedural documents • Excellent written and verbal communication skills, including telephone and face-to-face interactions • Excellent organization and time management skills • Proven ability to manage paperwork and files, handle multiple tasks, and deal effectively with stress • Strong attention to detail and accuracy • Strong problem-solving skills • Ability to work in an office environment with electrical office equipment • Potential drives to site locations and rare travel may be required • Ability to work varied hours on occasion

🏖️ Benefits

• Fully remote work arrangement • Health and wellbeing support • Healthy and balanced work environment • Collaboration and development opportunities • Reasonable accommodation for individuals with disabilities • Equal opportunity employment