Medical Monitor – Safety Administrator

🔥 0 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🖥️ Administration

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data • Track required data and generate reports for clients, project teams and external vendors • Represent the DSMB/EAC Coordination Team at global and domestic committee meetings, coordinating logistics and assisting with facilitation • Interface with internal and external parties to implement projects • Prepare and review Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements, coordinating approvals • Compile adjudication dossiers and create/submit follow-up to investigative sites • Coordinate and facilitate project meetings, draft minutes, post blinded and unblinded materials to client portals, and distribute materials • Manage project-specific training and program file setup, maintenance and archival while keeping pharmacovigilance audit ready • Identify and redact subject identifiers, retrain sites and escalate recurring issues to Data Privacy • Perform data entry into databases, tracking systems and budget management systems; reconcile systems to identify timeline-impacting issues • Oversee expenses and manage translations within budget parameters • Answer incoming hotline calls and coordinate department functions • Support local-office activities that cannot be performed elsewhere • Provide training to junior staff

🎯 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 at least 2 years • An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be sufficient • Strong problem-solving skills • Ability to work independently with minimal supervision • Ability to build strong relationships • Ability to analyze project-specific data/systems for accuracy and efficiency • Effective liaison and respectful, diplomatic communication with clients, management, project team members and internal staff • Effective oral, written communication and interpersonal skills • Excellent computer skills, including MS Office (Word, Excel, PowerPoint, Access) • Ability to prioritize and perform multiple tasks simultaneously under strict deadlines • Strong attention to detail and accuracy • 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 non-clinical and clinical project implementation, execution and closeout

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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