Safety Aggregate Report Coordinator - (1807664) in United States at IQVIA™

Date Posted: 8/11/2018

Job Snapshot

Job Description

Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health™. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.

Description

Manage the administrative and project support for service deliverables across the Safety Aggregate Reporting and Analytics (SARA) and Benefit Risk Management (BRM) Teams as appropriate. Deliverables include aggregate reports, literature and signal detection activities.
PURPOSE
Manage the administrative support for service deliverables across the Safety Aggregate Reporting and Analytics (SARA) and Benefit Risk Management (BRM) Teams as appropriate.
RESPONSIBILITIES
 Send Call for Information (CFI) to internal IQVIA departments and customers.
 Create relevant listings/necessary datasets where Quintiles maintains the safety database. Responsible for quality control of data reports and line listing and address any review findings on the data reports and line listings identified by internal quality control reviewer.
 Schedule and attend planning meetings and maintain the minutes of the meeting. Initiate and manage the workflow of controlled documents.
 Maintain SARA and BRM schedule/calendar of all contracted documents for all projects.
 Schedule and coordinate internal review(s) of the document. Reviews should be organized in time so that the other function can book sufficient time to do the review within the set timelines. Send the document for internal review according to established timelines.
 Prepare final formatting/compilation of document(s) including necessary attachments/appendices (e.g., CIOMS II line listings, etc.). Prepare submissions for Regulatory Authorities (RAs) and Ethics Committees ( ECs) (if regulatory consultant not contracted).
 May assist with creating project tracking spreadsheets and associated tracking entry specifications; assisting in database validation through performance of user testing; performing ad hoc database searches; escalating 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.
 Maintain and organize SARA and BRM electronic file systems
 Maintain and organize SARA and BRM SharePoint sites
 Participate in continuous improvement of all departmental processes and procedures by identifying and implementing efficiencies in workflow and safety publication.
 Involvement and contribution in local/global department committees e.g. Engagement, Admin, Quality initiatives

Job Requirements


JOB DESCRIPTION
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
 Good understanding of Good Clinical Practice (GCP), Good Pharmacovigiliance Practice (GVP) 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
 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.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
 High School Diploma or educational equivalent and 3 years’ relevant work experience; or equivalent combination of education, training and experience.
 

Job ID: 1807664