Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As a Drug Safety Admin Associate IV, you will have an integral part in ensuring the safety and efficacy of our products. Your meticulous attention to detail will help us successfully implement safety measures and compete in a global market.

A Day in the Life:

Conducting data entry and analysis for safety reportsCoordinating with cross-functional teams to determine safety protocolsCoordinating 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.Leads global departmental and vendor initiatives, including the identification and resolution of complex project support issues.Act as Subject Matter Expert for various PV processes and/or systems and authors critical and non-critical quality events; identifying, developing and implementing process improvements.Utilizes dashboards to evaluate and analyze data to resolve complex project support issues.Completes periodic quality reviews, gathers information for contract proposals and bidding algorithms and provides back-up support for PV management as requested.Develops and delivers training / training materials for new team members, prepares departmental SOPs / WPDs and supports management with project budgetary management tasks.Mentors junior staff.Job Complexity - Works on difficult or complex assignments requiring considerable judgment and initiative to resolve issues. Understands implications of work and makes recommendations for solutions and / or new procedures..Job Knowledge - As a skilled or highly skilled specialist, completes tasks in resourceful and / or creative ways, and may contribute to the development of concepts and techniques.Business Relationships - Contacts are frequent with individuals representing outside organizations, and / or individuals of significant importance within the company. Contacts involve planning and preparation of communications, requiring skill, tact, persuasion and / or negotiation to accomplish the objectives of the communication.