Associate 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
• Collect, monitor, assess, evaluate, research, and track safety information
• Enter, code, and assess adverse-event data
• Review cases and conduct follow-up activities
• Track reports and perform regulatory reporting activities
• 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 for quality, consistency, and accuracy, including peer reports
• Prepare and maintain regulatory safety reports
• Collaborate with project team members, client contacts, investigators, adverse-event reporters, and third-party vendors

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience comparable to 0 to 2 years
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• 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
• Previous exposure to Microsoft Office packages, including Outlook, Word, and Excel
• Understanding of medical terminology
• 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
• Willingness to work occasional long, varied hours
• Willingness to travel occasionally domestically and/or internationally

• Global team environment
• Collaboration and development opportunities
• Scientific excellence-focused workplace