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 organisation, minute taking, filing, photocopying, work distribution, reconciling reports, end of day emails completing metrics and updating PPD systems with project allocation.
Responsible for extracting and collating reporting information via the Clinical Trial Management System, maintain and update contact lists on PPD 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 PPD 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 organisation.
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 PPD or client.
Responsible for the coordination of study files and inventories to client, including distribution via external postal services as needed.
Education and Experience :
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities :
Ability 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 as well as face to face interactions with all levels of the organisation
Excellent organisation and time management skills, including those of paperwork and files, with proven ability to handle multiple tasks at once and deal effectively with stress
Strong attention to detail and accurate with orientation towards careful and meticulous work
Strong problem solving skills