Drug Safety Specialist

• Perform day-to-day pharmacovigilance activities in a highly regulated environment
• Participate in on-call duties for specific projects to ensure 24-hour case intake coverage
• Review pharmacovigilance publications and information sources to remain current on regulations, practices, procedures, and proposals
• Maintain medical understanding of applicable therapeutic areas and disease states
• Review cases for quality, consistency, and accuracy, including peer reports
• Prepare and maintain regulatory safety reports
• 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
• 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
• Collaborate with project team members, clients, 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

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 2+ years of previous relevant experience
• 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 processing adverse events
• 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 local language where required
• Computer literacy and ability to work within multiple databases
• Exposure to Microsoft Office packages, including Outlook, Word, and Excel
• 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 maintain a positive and professional demeanor in challenging circumstances
• Ability to work effectively within a team
• Ability to perform occasional domestic and/or international travel

• Global team environment at Thermo Fisher Scientific
• Collaboration and development opportunities
• Scientific excellence-focused work environment
• Occasional domestic and/or international travel opportunities