Senior Drug Safety Specialist – Night Shift

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🔥 38 minutes ago

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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

• Perform and may oversee day-to-day Pharmacovigilance activities in a highly regulated environment • Collect, monitor, assess, evaluate, research, and track safety information • Collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors • Participate in on-call duties for specific projects to ensure 24-hour case-intake coverage • Operate in a lead capacity • Assist with development of program and departmental procedural documents • Prepare for and attend audits • Mentor less experienced staff • Review regulatory and pharmacovigilance publications and information sources • Maintain medical understanding of applicable therapeutic areas and disease states • Review cases for quality, consistency, and accuracy, including peer reports • Coordinate routine project implementation, including clinical trials and post-approval activities • Present at client meetings and review metrics and budget considerations

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 5+ years of comparable experience • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • Thorough understanding of pathophysiology and disease processes • Strong knowledge of relevant therapeutic areas for adverse-event processing • Critical thinking and problem-solving skills, with ability to evaluate and escalate appropriately • Complex clinical study administration experience, including budget activities and forecasting • Excellent oral and written communication and 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, including Outlook, Word, and Excel • Thorough understanding of global regulatory requirements and compliance with procedural documents and regulations • Ability to manage and prioritize varied tasks and meet strict deadlines with limited supervision • Strong attention to detail • Ability to maintain a positive and professional demeanor in challenging circumstances • Ability to work effectively within a team

🏖️ Benefits

• Collaboration and development opportunities • Occasional domestic and/or international travel • Reasonable accommodation for individuals with disabilities • Equal opportunity employment