Safety Reporting Coordinator

Overview

The Safety Reporting Coordinator provides administrative safety support to the Pharmacovigilance department, focused on safety report submissions, tracking, filing, archiving and reconciliation for expedited and periodic safety reports.

What you'll do

• Responsible for the submission of safety reports to applicable parties, including scanning, indexing and filing (electronic and paper), safety tracker completion and quality check, and archiving in accordance with SOPs and WPDs.
• Resolve simple problems with submission packs with minimal input from your manager or other administrators.
• Provide assistance and liaise with relevant teams and departments on a range of administrative safety reporting tasks, including audit readiness activities, meeting organization, minute taking, filing, photocopying, work distribution, reconciling reports, end of day emails, completing metrics and updating the organization's systems with project allocation.
• Extract and collate reporting information via the Clinical Trial Management System, and maintain and update contact lists on the organization's systems as required by Safety Specialist or Safety Reporting Specialists.
• Support department and Pharmacovigilance initiatives as relevant.
• Train Pharmacovigilance department staff on the safety reporting process and the organization's systems associated with safety reporting.
• Assist with filing support for multiple projects, including barcoding of safety reports, filing of safety reports, identification and reporting of problems and inaccuracies to management, and responsibility for the file room's cleanliness and organisation.
• Assist with file reviews for completed safety reports, maintain audit notification and file return notification forms, and assist with on-site audits if required or requested by the organization or client.
• Coordinate study files and inventories to the client, including distribution via external postal services as needed.

What you'll need

• Bachelor's Degree or equivalent and relevant formal academic / vocational qualification.
• Technical positions may require a certificate.
• Previous experience comparable to at least 2 years, or an equivalency of appropriate education, training and/or directly related experience.
• Know how to work effectively in a team to attain a shared goal and support assigned lead and line manager on tasks.
• Proficiency in Microsoft Office Programs (Word, Excel, PowerPoint, Access) and solid knowledge of procedural documents.
• Excellent written and verbal communication skills, including telephone conversations and face-to-face interactions with all levels of the organization.
• Excellent organization and time management skills, including for paperwork and files, with proven ability to handle multiple tasks at once and deal effectively with stress.
• Strong attention to detail, accurate and meticulous in work.
• Strong problem solving skills.

Details

• Work schedule: Standard (Mon-Fri), with long varied hours required on occasion.
• Work is performed in an office environment with exposure to electrical office equipment; majority of work is computer-based.
• Potential drives to site locations and/or travel required on rare occasion.