Summarized Purpose :
Provides administrative safety support to the Pharmacovigilance department, specifically in relation to submission, tracking and subsequent filing and archiving of expedited and periodic safety reports.
This includes other general administration tasks such as filing, photocopying, typing and performing reconciliation tasks.
Participates in projects relating to safety reporting.
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.
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, 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.
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.
Supports department and Pharmacovigilance initiatives as relevant.
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 0 to 1 year).
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 basic knowledge of procedural documents
Excellent written and verbal communication skills, including telephone conversations as well as face to face interaction internally within the department
Ability to identify and prioritise tasks simultaneously along with handling numerous deadlines and stay focused during these times.
Ability to work under pressure without jeopardizing work standards
Excellent organisation and time management skills, including those of paperwork and files
Strong attention to detail and accurate with orientation towards careful and meticulous work
Management Role :
No management responsibility
Working Conditions and Environment :
Work is performed in an office environment with exposure to electrical office equipment
Potential drives to site locations and / or travel required on rare occasion
Majority of work computer-based
Long varied hours required on occasion
Physical Requirements :
Frequently stationary for 4-6 hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
Occasional mobility required
Occasional crouching, stooping, bending and twisting of upper body and neck
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups
Works independently with guidance or reliance on oral or written instructions and plans work schedules to meet goals
Requires multiple periods of intense concentration
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
Ability to perform under stress and multi-task
Regular and consistent attendance
PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.
Requisition ID : 157707