Safety Reporting Coordinator

• Provide administrative safety support to the Pharmacovigilance department
• Submit safety reports to applicable parties and complete scanning, indexing, filing, tracking, quality checks, and archiving in accordance with SOPs and WPDs
• Resolve simple problems with submission packs
• Liaise with relevant teams on administrative safety reporting tasks, audit readiness, meeting organization, minute taking, filing, photocopying, work distribution, report reconciliation, metrics, and system updates
• Extract and collate reporting information via the Clinical Trial Management System
• Maintain and update contact lists in organizational systems
• Support department and Pharmacovigilance initiatives
• Train Pharmacovigilance staff on safety reporting processes and associated systems
• Provide filing support, barcode safety reports, identify inaccuracies, and maintain file-room cleanliness and organization
• Assist with completed safety report file reviews, audit notifications, file return notifications, and on-site audits
• Coordinate study files and inventories for clients, including distribution through external postal services

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• Previous experience comparable to at least 2 years
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Proficiency in Microsoft Office Programs (Word, Excel, PowerPoint, Access)
• Solid knowledge of procedural documents
• Excellent written and verbal communication skills
• Excellent organization and time management skills
• Proven ability to handle multiple tasks simultaneously and deal effectively with stress
• Strong attention to detail and accuracy
• Strong problem-solving skills
• Ability to work effectively in a team and support assigned lead and line manager
• Occasional travel or drives to site locations may be required

• Meaningful work with a positive global impact
• Resources to achieve individual career goals
• Collaboration and professional development opportunities
• Fully remote work arrangement
• Standard Monday–Friday work schedule