Safety Specialist

• Perform day-to-day pharmacovigilance activities
• Review regulatory/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
• Prepare and maintain regulatory safety reports
• Coordinate and perform data entry, coding, adverse-event assessment, case review, follow-up, report tracking, and regulatory reporting
• Assist with routine project implementation and coordination for clinical trials and safety committees
• Present at client and investigator meetings
• Review metrics and budget considerations
• Mentor less experienced staff
• Collaborate with project team members, client contacts, investigators, adverse-event reporters, and third-party vendors
• Assist in preparing 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 comparable previous experience
• 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, 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
• Equivalency through a combination of appropriate education, training, and/or directly related experience may satisfy role requirements

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