Senior Safety Committee Specialist – DSMB

🔥 14 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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👻 Ghost score 10%

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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

• Lead complex safety projects and support successful implementation of pharmacovigilance practices • Perform CEC/DSMB study start-up activities, including charter development, member contracting, and electronic adjudication system build • Perform CEC/DSMB close-out activities • Act as company liaison for CEC/DSMB with sponsors • Assist project teams in executing CEC/DSMB strategies • Independently manage day-to-day CEC/DSMB activities using specialty committee processes and procedures • Review adjudication/DSMB publications and information sources for current regulations, practices, procedures, and proposals • Maintain medical understanding of applicable therapeutic areas and disease states • Prepare and quality-check CEC dossier compilation and submission • Maintain secure files for DSMB unblinded data • Assist with project implementation and coordination, including client/investigator presentations and review of metrics and budgets • Assist in preparing departmental and project-specific procedures and processes • Prepare for and attend audits, kick-off meetings, and investigator meetings representing CEC/DSMB functions • Collaborate with global teams

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalency may consist of a combination of appropriate education, training and/or directly related experience • Thorough understanding of pathophysiology and disease processes • Strong knowledge of relevant therapeutic areas for CEC and/or DSMB review • Excellent critical thinking and problem-solving skills • Excellent oral and written communication skills, including paraphrasing skills • Good command of English and ability to translate information into local language where required • Computer literacy and ability to work within multiple databases • Proficiency in Microsoft Office packages, including Outlook, Word, and Excel • Thorough understanding of procedural documents and regulations • Ability to manage and prioritize varied tasks and meet strict deadlines with limited supervision • Strong attention to detail • Ability to work effectively within a team • Ability to travel occasionally, domestically and internationally • Regular and consistent attendance • Ability to perform required physical activities, including stationary work, repetitive hand movements, mobility, occasional bending, and lifting 15–20 lbs

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Scientific excellence-focused workplace • Occasional domestic and international travel