Drug Associate Safety Administrator

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As Associate Safety Admin, you'll 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 diagnostics. In 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 You’ll 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 PPD's 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 organization's/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. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.