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.
Opportunity for individuals interested in stable long term job with administrative tasks in the field of Pharmacovigilance, Drug Safety and Medical Information!
Manage the administrative support across all Lifecycle Safety service lines to the Standard Operation and it's functions as appropriate. Provide support to administrative team members.
- 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, 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 e.g. project start-up tasks, creation and maintenance of project files, systems access requests; periodic distribution of AE listings; and shipping of information supplies to sites as directed by senior operations team member.
- • May coordinate, schedule and submit safety reports to regulatory authorities, marketing authorization holders, investigators, customers and operations team in accordance with deadlines; perform project administrative tasks such as creation of labels using investigator list, maintenance of personal safety files for mail merges and regulatory documents, copying of documents, envelope stuffing, tracking and filing of submission dossiers, and distributing listings to client and/or operations team members.
- • Creating, 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 company/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.
- • May assist with system support tasks such as utilizing design specifications, study form, and protocol to create project specific entry specifications and annotated project forms for database under guidance from operations lead and/or manager; creating project tracking spreadsheets and associated tracking entry specifications; assisting in database validation through performance of user testing; performing ad hoc database searches for operations team leads; assisting operations team member in assessing database setup needs; assist with project phone/fax line set-up as required; 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.
- • Identify and record process or quality problems and bring them to the attention of a senior team member.
- • Participate in continuous improvement of all departmental processes and procedures by identifying and implementing efficiencies in workflow and/or case processing.
- • Involvement and contribution in local/global department committees e.g. Engagement, Admin, Quality initiatives
- • Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- • Good team work skills
- • Problem solving skills
- • Results and detail-oriented approach to work delivery and output
- • Ability to prioritize own workloads to meet deadlines
- • Strong software and computer skills, including MS Office applications
- • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- • Strong verbal/written communication skills in English language - any additional language is an asset
- • Willingness and aptitude to learn new skills across all Lifecycle Safety service lines.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
High School Diploma and 3 years' relevant experience; or equivalent combination of education, training and experience.
- • Extensive use of keyboard requiring repetitive motion of fingers.
- • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- • Regular sitting for extended periods of time.
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.
Job ID: R1093419