Drug Safety Specialist – Day Shift

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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 day-to-day pharmacovigilance activities in a highly regulated environment • Collect, monitor, assess, evaluate, research, and track safety information • Perform data entry, coding, adverse-event assessment, case review, follow-up, report tracking, and regulatory reporting • Collaborate with project team members, client contacts, investigators, adverse-event reporters, and third-party vendors • Assist with departmental and project-specific procedures and processes • Prepare for and attend audits, kick-off meetings, and investigator meetings • Participate in on-call duties for specific projects to support 24-hour case intake coverage • Review pharmacovigilance publications and information sources to stay current on regulations, practices, procedures, and proposals • Maintain medical understanding of applicable therapeutic areas and disease states • Review cases and peer reports for quality, consistency, and accuracy • Prepare and maintain regulatory safety reports • Assist with routine project implementation and coordination, including clinical trials and safety monitoring committees • Present at client and investigator meetings • Review metrics and budget considerations • Mentor less experienced staff

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • Minimum 2 years of previous experience in pharmacovigilance case processing, triage, and/or peer review • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • General understanding of pathophysiology and disease processes • Detailed knowledge of relevant therapeutic areas for adverse-event processing • Strong critical thinking and problem-solving skills • Good oral and written communication skills, including paraphrasing skills • Good command of English and ability to translate information into the local language where required • Computer literacy and ability to work within multiple databases • Previous exposure to Microsoft Office packages, including Outlook, Word, and Excel • Understanding of procedural documents and regulatory compliance • 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 to attain a shared goal • Willingness to travel domestically and/or internationally on occasion

🏖️ Benefits

• Global team environment focused on collaboration and development • Reasonable accommodation for individuals with disabilities • Equal opportunity employment