Drug Safety Reporting Coordinator

• Submit safety reports to applicable parties
• Scan, index, file, track, quality-check, and archive safety reports in accordance with SOPs and WPDs
• Resolve simple submission-pack problems with minimal supervision
• Liaise with relevant teams and departments on administrative safety-reporting tasks
• Support audit-readiness activities, 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 related systems
• Provide filing support for multiple projects, including barcoding and identifying/reporting inaccuracies
• Maintain file-room cleanliness and organization
• Assist with completed safety-report file reviews and audit notification/file return forms
• Provide assistance during on-site audits when required
• Coordinate study files and inventories to clients, including distribution through external postal services
• Mentor or train new central safety reporting administrative staff as needed

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• At least 2 years of previous experience providing the knowledge, skills, and abilities to perform the job
• Equivalency may be considered through a combination of appropriate education, training and/or directly related experience
• 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 and deal effectively with stress
• Strong attention to detail and accuracy
• Strong problem-solving skills
• Ability to work effectively in a team
• Potential ability to drive to site locations and travel on rare occasions

• Fully remote work mode
• Standard Monday–Friday work schedule
• Career development and training opportunities
• Global team environment
• Opportunity to support meaningful work in clinical research and life-changing therapies