Safety Reporting Coordinator

Job Description

Summarized Purpose: Provides administrative safety support to the Pharmacovigilance department. Specifically in relation to submissions, tracking and subsequent filing and archiving or expedited and periodic safety reports. This includes other general administration tasks such as filing, photocopying, typing and performing reconciliation tasks. Involved in projects relating to safety reporting. May mentor or train new central safety reporting admin staff.

Essential Functions and Other Job Information

• Responsible for the submission of safety reports to applicable parties, including subsequent scanning, indexing and filing (both electronic and paper), safety tracker completion and quality check, and archiving in accordance with SOP’s and WPD’s. Resolves simple problems with submission packs within minimal input from manager or other administrators. 

• Provides assistance and liaises with relevant teams and departments on a various 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.

• Responsible for extracting and collating reporting information via the Clinical Trial Management System, maintain and update contact lists on the organization's systems as required by Safety Specialist or Safety Reporting Specialists.

• Supports department and Pharmacovigilance initiatives as relevant.

• Responsible for training Pharmacovigilance department staff on the safety reporting process and various organization's systems associated with safety reporting. 

• Assists when required, to provide filing support for multiple projects, including barcoding of safety reports, filing of safety reports, identification and reporting of any problems and inaccuracies to management, as well as responsibility for the file room in terms of cleanliness and organization.

• Assists with file reviews for completed safety reports, maintains audit notification and file return notification forms and provides assistance with on-site audits if required or requested by the organization or client. Responsible for the coordination of study files and inventories to client, including distribution via external postal services as needed.