Senior Drug Safety Specialist – Night Shift

• Perform and potentially oversee day-to-day Pharmacovigilance activities in a highly regulated, deadline-driven environment
• Collect, monitor, assess, evaluate, research, and track safety information
• Collaborate with project team members, clients, investigators, adverse-event reporters, and third-party vendors
• Participate in on-call duties for specific projects to ensure 24-hour coverage for case intake 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/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
• Coordinate routine project implementation, including Clinical Trials and Endpoint Assessment/Data Safety Monitoring Committees
• 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 the knowledge, skills, and abilities to perform the job
• Equivalent 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 adverse-event processing
• Excellent critical thinking and problem-solving skills; ability to evaluate and escalate appropriately
• Proficiency in complex clinical study administration, including budgets and forecasting
• Excellent oral and written communication, 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
• 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
• Full-time employment
• Standard Monday–Friday schedule
• Potential on-call duties for 24-hour case-intake coverage
• Occasional domestic and/or international travel
• Mentoring and professional development through collaboration and development opportunities