Thermo Fisher Scientific
10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
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.
Senior Drug Safety Specialist – Day Shift
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Thermo Fisher Scientific
10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
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
• Works independently to perform day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites. • Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less experienced staff. • Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states. • Reviews cases entered for quality, consistency and accuracy, including review of peer reports. • Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations.
🎯 Requirements
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Must have PV (Clinical Trial or Post-marketed) case processing experience of no less than 4 years. Familiar with Argus database. • Thorough understanding of pathophysiology and the disease process • Strong knowledge of relevant therapeutic areas as required for processing AEs • Excellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately • Proficient at complex clinical study administration including budget activities and forecasting • Excellent oral and written communication skills including paraphrasing skills • Good command of English and ability to translate information into local language where required • Computer literate with the ability to work within multiple databases • Proficient in Microsoft Office products (including Outlook, Word, and Excel)
🏖️ Benefits
• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development
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