Drug Safety Associate

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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

• Coordinate timely review of protocol inquiries, triage abnormal lab alerts and diagnostics, track necessary data, and generate reports for clients, project teams, and external vendors • Identify and redact subject identifiers per local requirements; retrain sites and escalate recurrences to PPD Data Privacy • Manage project-specific training with the project lead/manager, including applying training in the learning management system • Perform data entry into tracking systems and system reconciliations to identify issues that may affect project timelines • Coordinate and facilitate project/client meetings, draft minutes, post to client portals, and distribute materials to internal and external teams • Manage setup, maintenance, and archival of program files in PPD's electronic filing system • Liaise with internal functional groups to implement projects and ensure contractual obligations and timelines are met • Answer incoming hotline calls and forward information from the Incoming Information Center to designated teams • Support activities performed by the local office that cannot be performed remotely

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Technical positions may require a certificate • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 1 year • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered sufficient • Effective oral and written communication and interpersonal skills • Excellent computer skills, including MS Office (Word, Excel, PowerPoint, Access) • Ability to identify and set priorities and perform multiple tasks simultaneously under strict deadlines • Strong attention to detail and accuracy • Ability to work independently or in a team with moderate supervision • Ability to maintain a positive and professional demeanor in challenging circumstances • Flexibility to reprioritize workload to meet changing project timelines • Working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and organizational/client SOPs and WPDs for project implementation, execution, and closeout

🏖️ Benefits

• Fully remote work • Collaboration and development as part of the everyday experience • Reasonable accommodation for individuals with disabilities • Equal opportunity employment