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.
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.
+ Assist inprocessing of Lifecycle Safety data by collecting and trackingincomingAdverseEvents(AE)/endpointinformation;determininginitial/updatestatus of incomingevents;trackingtimelines for completionofeventprocessing;distributing eventinformationtoappropriateprojectpersonnel in theworkflow for continuedprocessing;review and preparation of endpointdocumentation;transfer of eventstoclientandotherparties as identified by operationslead;obtainingconfirmation of reportreceipt and tracksubmission; and assumingworkflowresponsibilities for variousprojects.
+ May assist withprojectworkflow including database entry,quality controlactivities,and generation of LifecycleSafety data reports,preparation of Lifecycle Safety submissiondossiers,assistingwithdeadlinequalitymeasurements, as directed by operationsteam member or manager.
+ Assist withadministrativeteamsupporte.g.project start-up tasks, creation and maintenance of projectfiles,systemsaccessrequests;periodicdistributionof AE listings;andshipping of informationsupplies to sitesasdirected by senioroperationsteam member.
+ Maycoordinate,schedule and submit safety reports to regulatoryauthorities,marketingauthorizationholders,investigators,customers and operationsteaminaccordancewithdeadlines;performprojectadministrativetasks such as creation of labelsusinginvestigatorlist,maintenance of personalsafety filesformailmergesandregulatorydocuments,copying of documents,envelopestuffing,trackingandfiling of submission dossiers, and distributinglistings to client and/or operationsteammembers.
+ Creating,maintain and track casefolders;filing,retrievinganddistribution of case folderstooperationsteam members;assisting in maintenance of documentcontrolstorageandrelevantapplications/systemsas directed. Archivingcasefoldersandprojectfilesaftereventclosure;coordination of transfer of archivedmaterial to company/customerarchivestoragefacilities after studyclosure;assistingincreationofrecords managementprocessesandprocedures;providing key input to operations teamonacquisitionand/orupgradeofrecords managementapplication/systems; and servingasliaisonbetweenLifecycleSafetydepartment and recordsmanagementdepartment.
+ May assist withsystem supporttasks such asutilizingdesignspecifications, study form,andprotocol to createprojectspecificentry specifications andannotatedprojectforms for database under guidancefromoperationsleadand/ormanager; creating projecttrackingspreadsheets and associatedtracking entry specifications;assisting in databasevalidationthroughperformance of usertesting;performingadhocdatabasesearches for operationsteamleads;assistingoperationsteam member in assessingdatabasesetupneeds;assistwithprojectphone/fax line set-up asrequired;escalating any system/equipment problem.
+ Overseeandco-ordinate administrativesupport by coordinatingteam/department/customer/projectoversightgroupmeetings,coordinatingstationeryorders,dispatchingdocumentsviacourierservices,reservingmeetingroomsand IT equipment;andprovidingadministrativesupportwhererequired.
+ Identify and recordprocess or quality problemsandbringthem to the attention of a seniorteam member.
+ Providetraining/mentoring to new/lessexperiencedstaff.
+ Participate in continuousimprovement of alldepartmentalprocessesandprocedures by identifyingandimplementingefficienciesinworkflowand/orcase processing.
+ Co-ordinate,overseeanddelegateresourcetasks to administrativeteam membersasappropriateandmonitortheintake of casesandarchivingprocesswhenmultiplecoordinatorsareinvolved.
+ Involvementandcontributioninlocal/globaldepartmentcommittees e.g. Engagement,Admin,Quality initiatives
+ Perform other duties as assigned. **REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**
+ Goodunderstanding of Good Clinical Practice(GCP) and InternationalConferenceonHarmonization(ICH)guidelinesStandardOperatingProcedures (SOPs) andworkinstructionsapplicable to the role.
+ Goodworkingknowledge of Microsoft Officeandweb-basedapplications.
+ Strong organizationalskillsandtimemanagement skills.
+ Strong verbal/writtencommunication skills.
+ Ability tofollowinstructions/guidelines,utilizeinitiativeandworkindependently.
+ Provenability to multi-task,managecompetingprioritiesand deadlines.
+ Ability todelegateandmentoreffectively to lessexperienced team members.
+ Willingnessandaptitudetolearn new skillsacrossallLifecycle Safety service lines. **MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
+ High SchoolDiploma or educationalequivalentand 2 years’relevantworkexperience; or equivalentcombination of education,trainingandexperience.
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
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