Senior Safety Specialist

• Perform and potentially 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 from investigative sites
• Operate in a lead capacity and assist with developing 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 and peer reports for quality, consistency, and accuracy
• Coordinate routine project implementation, including Clinical Trials and Endpoint Assessment Committee/Data Safety Monitoring Committee activities
• Present at client and investigator meetings
• Review metrics and budget considerations

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 5+ years of previous experience providing relevant knowledge, skills, and abilities
• 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 processing adverse events
• Critical thinking and problem-solving skills, including appropriate evaluation and escalation
• Proficiency in complex clinical study administration, budget activities, and forecasting
• Excellent oral and written communication skills, including paraphrasing
• Good command of English and ability to translate information into the 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 to attain a shared goal

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Collaboration and professional development within a global team
• Mentoring opportunities
• Participation in a global team committed to scientific excellence