Drug Associate Safety Administrator

Work Schedule

Environmental Conditions

Job Description

Join Us as a Associate Safety Admin Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

As part of our expert team youll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As Associate Safety Admin youll play a key role in providing contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events protocol inquiries and physician assessment of collaboration with Safety Specialists and Medical Monitors you will liaise and establish effective relationships with functional team members to accurately manage all incoming safety documentation.

What Youll Do:
Coordinating the timely review of protocol inquiries triage of abnormal lab alerts and diagnostics tracking all necessary data and generating reports for the client project team and/or external vendors.

Identifies and redacts subject identifiers per local requirements; retraining sites and escalates reoccurrences to PPD Data Privacy.
Manages project specific training in collaboration with the project lead/manager including the application of training within the learning management system.
Performs data entry into tracking systems and performs system reconciliations to identify issues which may negativley impact project timelines.
Coordinates and facilitates project and/or client meetings drafts meeting minutes posts to client portals and distributes to internal and external project teams.
Manages the set-up maintenance and archival of program files within PPDs electronic filing system.
Liaises with various internal function groups to implement projects ensuring contractual obligations are met and timelines are achieved.
Answers incoming hotline calls forwards information received at the Incoming Information Center (IIC) to the designated teams.
Supports any specific activities performed by the local office which cannot be performed from elsewhere.

Education and Experience Requirements:
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).

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:
Self-motivated positive attitude with effective oral and written communication and interpersonal skills
Excellent computer skills to include: MS Office (Word Excel PowerPoint Access)
Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines
Strong attention to detail and accuracy with orientation toward careful and meticulous work
Ability to work in a team or independently demonstrating initiative to complete assigned tasks with moderate supervision
Ability to maintain a positive and professional demeanor in challenging circumstances
Flexibility to reprioritize workload to meet changing project timelines
Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations ICH Good Clinical Practices and the organizations/Client SOPs and WPDs forall non-clinical/clinical aspects of project implementation execution and closeout


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

Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.