IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Job Overview

Manage the administrative support across all Lifecycle Safety service lines to the SO and LSM functions as appropriate. Provide support to junior administrative team members.

Essential Functions:

• Provide data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and marketed product safety activities.
• Triages, tracks, and processes safety data; assesses safety data for report-ability to the client safety department or relevant regulatory bodies; maintains communication with marketed product reporters to obtain accurate data regarding safety events; and contributes to lifecycle safety deliverables.
• Assist in processing of Lifecycle Safety data by collecting and tracking incoming Adverse Events(AE)/endpoint information, determining initial/update status of incoming events, tracking timelines for completion of event processing, distributing event information to appropriate project personnel in the workflow for continued processing, review and preparation of endpoint documentation, transfer of events to client and other parties as identified by operations lead, obtaining confirmation of report receipt and track submission and assuming workflow responsibilities for various projects.
• May assist with project workflow including database entry, quality control activities, and generation of Lifecycle Safety data reports, preparation of Lifecycle Safety submission dossiers, assisting with deadline quality measurements, as directed by operations team member or manager.
• Assist with administrative team support
• May coordinate, schedule and submit safety reports
• Create, maintain and track case folders, filing, retrieving and distribution of case folders to operations team members, assisting in maintenance of document control storage and relevant applications/systems as directed
• Archiving case folders and project files after event closure, coordination of transfer of archived material to customer archive storage facilities after study closure, assisting in creation of records management processes and procedures, providing key input to operations team on acquisition and/or upgrade of records management application/systems and serving as liaison between Lifecycle Safety department and records management department
• Create project tracking spreadsheets and associated tracking entry specifications
• Assist in database validation through performance of user testing
• Perform ad hoc database searches for operations team leads
• Assist operations team member in assessing database setup needs
• Assist with project phone/fax line set-up as required
• Escalate any system/equipment problem
• Oversee and co-ordinate administrative support by coordinating team/department/customer/project oversight group meetings, coordinating stationery orders, dispatching documents via courier services, reserving meeting rooms and IT equipment and providing administrative support where required. Identify and record process or quality problems and bring them to the attention of a senior team member.
• Provide training/mentoring to new/less experienced staff.
• Participate in continuous improvement of all departmental processes and procedures by identifying and implementing efficiencies in workflow and/or case processing.
• Co-ordinate, oversee and delegate resource tasks to administrative team members as appropriate and monitor the intake of cases and archiving process when multiple coordinators are involved
• Involvement and contribution in local/global department committees
• Perform other duties as assigned.

Qualifications:

• High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences
• At least 1 year of relevant work experience
• Good understanding of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Standard Operating Procedures (SOPs) and work instructions applicable to the role
• Good working knowledge of Microsoft Office and web-based applications
• Good knowledge of medical terminology
• Strong organizational skills and time management skills
• Strong verbal/written communication skills
• Self-motivated and flexible with excellent attention to detail and accuracy
• Ability to follow instructions/guidelines, utilize initiative and work independently
• Proven ability to multi-task, manage competing priorities and deadlines.
• Willingness and aptitude to learn new skills across all Lifecycle Safety service lines
• Ability to follow instructions/guidelines, utilize initiative and work independently
• Proven ability to multi-task, manage competing priorities and deadlines
• Willingness and aptitude to learn new skills across all Lifecycle Safety service lines

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.