Operations Co-ordinator - Pharmacovigilance
Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward
Under supervision provide administrative support across all Lifecycle Safety service lines to the SO and LSM functions as appropriate.
Assist in processing incoming and outgoing Lifecycle Safety data and reports i.e. collecting and tracking incoming Adverse Event (AE) and endpoint reports; determining initial/update status of incoming events; and tracking timelines for completion of events. As required, assist with entering data into Lifecycle Safety databases, submitting event data to Operational Team members, tracking submission, and assume workflow responsibilities for assigned projects.
Prepare documents, files for meetings and committees where required i.e. endpoint duplication/dossier compilation oversight committees; and any other project related meetings.
Co-ordinate and check incoming documents from sites; review with checklist; ensure documents meets requirements in advance of further level review in conjunction operations team member.
Create, track and archive case folders and project files across Lifecycle Safety service lines. File, retrieve and deliver case folders; assist in maintenance of document control room where required and support relevant applications/systems as directed by Operations Team member.
Assist with the distribution of Lifecycle Safety data to investigators, marketing authorization holders, customers and regulators. May coordinate, schedule and submit reports to regulatory authorities in accordance with established deadlines. Assist with investigator mailings by creating labels using investigator lists, copying documents, stuffing envelopes, dispatching data using courier services and tracking and filing submitted materials.
Document completion tasks under guidance from Operations Team member.
Assist with administrative team support e.g. project start-up tasks’ creation and maintenance of project files, periodic distribution of AE listings; and shipping information supplies to sites.
Coordinate team/department/customer meetings, reserve meeting rooms and IT equipment and prepare department stationery and supply orders.
Promote understanding of work instructions for use of all relevant electronic systems and maintenance of records.
Identify and report to senior team member any issues with tracking, document and process-related systems, including problems with incoming faxes.
Oversee intake of cases and archiving process when multiple coordinators are involved.
Collaborate with operations and other functional groups to help achieve business goals.
Involvement and contribution in local department committees e.g. Engagement, Admin, Quality initiatives.
Performs work in accordance with governing SOPs; work instructions and regulatory requirements.
May be assigned to function across multiple projects, simultaneously.
Perform other duties as assigned.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role.
Experience and expertise with relevant computer systems and operating environments is desired.
Basic knowledge of medical terminology.
Self-motivated and flexible.
Ability to follow instructions/guidelines, utilize initiative, work independently.
Good organizational and time management skills. Ability to manage competing priorities.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Willingness and aptitude to learn new skills across all Lifecycle Safety service lines.
Deal professionally with internal customers competing concurrently for attention, services and resources.
Willingness and aptitude to learn new skills across all Lifecycle Safety service lines.<span style
- Clinical Pharmacology
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