Drug Safety Admin Associate I

• Coordinates 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, PV Lead, and the Project specific training team, 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 negatively 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.
• Supports any specific activities performed by the local office, which cannot be performed from elsewhere.
• Job Complexity - Works on assignments that are routine in nature, requiring limited judgment. Has little or no role in decision-making.
• Job Knowledge - Acquires job skills and learns company policies and procedures to complete routine tasks.
• Supervision Received - Normally receives detailed instructions on all work. Works under close supervision.
• Business Relationships - Contacts are primarily within immediate work unit. Contacts involve obtaining or providing information requiring little explanation or interpretation.

• 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).
• 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.

• 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 for all nonclinical/clinical aspects of project implementation, execution and closeout

• 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

• 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

Thermo Fisher Scientific