Senior/Principal Drug 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
• Participate in on-call duties for specific projects to ensure 24-hour case-intake coverage
• Lead activities and assist in 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 for quality, consistency and accuracy, including peer reports
• Coordinate routine project implementation, including clinical trials and safety committees
• Present at client and investigator meetings
• Review metrics and budget considerations
• Collaborate with project teams, clients, investigators, adverse-event reporters and third-party vendors

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 5+ years of previous relevant experience
• Equivalent combination of 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
• 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 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 procedural compliance
• 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
• Occasional domestic and/or international travel required

• Collaboration and development opportunities
• Opportunity to contribute to patient safety and scientific excellence
• Global team environment
• Occasional domestic and international travel