药物安全定期性报告高级专员社

20K-30K/月

市辖区

发布时间：2023-09-06

职位描述

职位描述：

药物安全定期性报告高级专员
SafetyAggregateReportSeniorSpecialist

Applyknowledgeandexpertiseincludingcomplexdecisionmakingactivitiestoreview,assessandprocessLifecycleSafetydataandinformationacrossallservicelines.Recognizedasspecialistinoneormoreareas.Provideoversightonsmalltomediumserviceoperationalprojectsandactasmentortojuniormembersofstaff.
RESPONSIBILITIES
?Receive,triage,reviewandprocessLifecyclesafetyoperationaldatafromvarioussourcesontime,withinbudgetandqualitystandards.PerformdataentryfortrackingandLifecyclesafetydatabases,codingrelevantmedicalterminology,writingdescriptnarratives,generatingqueriespertinenttothecase,performingqualitycontrol,assistingwithreconciliation,drivingcaseclosure,coordinatingtranslationsandensuringreportsaresenttothecustomerwithinassigneddeadlines.Pre-processmaterialforendpointcommitteeorcorelaboratoryadjudication.Preparationofmaterialforsubmission.
?AssessLifecyclesafetydataforreportabilitytorelevantauthorities,trackreportablecasesandreporttoregulatoryauthorities,ethicscommittees,institutionalreviewboards,investigators,oversightgroupsperlegislation,withintimelinesandinaformatcompatibletorequirement.LiaisewithlocalQuintilesofficestofacilitateexpeditedreporting.Liaisewithsystemsmanagerforregulatorytrackingrequirementsandelectronicreporting.
?ContributeknowledgeandexpertisetoorleadassigneddeliverablesinthefieldofSafetyPublishing,RiskManagement,SafetySurveillanceandMedicalInformationorotherservicelinesasappropriate.
?Receiveanddocumentincomingtelephonecalls,faxesoremailsfrominvestigativesitesorothersourcesreportingoperationaldata.
?ProcessLifecyclesafetydataaccordingtoapplicableregulations,guidelines,StandardOperatingProcedures(SOPs)andprojectrequirements.
?Buildapositive,collaborativeteamenvironmentwithLifecyclesafetyteammembers,leadbyexample,providetrainingandmentoringforlessexperiencedteammembersandoperationsstaff,assistOperationswithappropriateallocationofresource.
?Provideoversightroleandhaveagoodunderstandingofoperationalteamonstatus,metrics,productivityandinitiatives.
?ProvideandimparttechnicalandprocessinformationtoLifecycleSafetyManagement(LSM)andmembersofoperationalteamonprojectspecificissues.
?Provideoversightandmaintainathoroughunderstandingofprojectprotocol,therapeuticindication,budgetandscopeofwork(SOW)forassignedprojects;setupandmaintainprojectfiles,standards,templates,electronicforums,databasesandworkflow.
?Establishandmaintaineffectiveteamprojectserviceoperationscommunicationsi.e.provideregularfeedbacktooperationsteammanagerandCustomerDeliverymanager(CDM)onprojectmetrics,outofscopeworkchallenges/issuesandsuccesses;feedbackeffectiveprojectperformancetojuniormembersofteam.
?LiaisewithLSMcontactinproactivelyidentifyingissuesandproposingsolutions,providingthemwithtechnicalsupport,reports,metrics,statuses,identifyingSOWchangesandpotentialchangeorders,delegatingclientrequestsandinstallationofnewinitiatives.
?EnsurecompliancetoQuintileshighqualitystandardsandworkswithLSMconstructivelyinamatrixframeworktoachieveprojectandcustomerdeliverables.
?ParticipateintrainingacrossLifecyclesafetyprocessserviceofferings,participateinworkinggroupsasapplicableinimplementationofnewinitiatives,identificationandimplementationofprocessefficiencies.
?Liaiseconfidentlywithdifferentfunctionalteammembers,e.g.projectmanagement,clinical,datamanagement,healthcareprofessionalse.g.investigators,medicalmonitors,sitecoordinatorsanddesigneestoaddressoperationalprojectissues.
?Contributetoachievingproductivityutilizationandrealizationmetrics.
?ReadandacknowledgeallnecessaryQuintilesstandardoperatingprocedures(SOPs)andcustomerSOPsasrequired.
Ensureallrequiredtrainingisexecutedinatimelyfashionanddocumented.Worktowardsensuringyourindividualtrainingplanandtrainingtranscriptarereconcilable.
?Performotherdutiesasassigned.
REQUIREDKNOWLEDGE,SKILLSANDABILITIES
?IndepthknowledgeofLifecyclesafetyprocessesandwillingnessandaptitudetolearnnewskillsacrossLifecyclesafetyservicelines.
?Indepthknowledgeandunderstandingofapplicableglobal,regional,localclinicalresearchregulatoryrequirements;i.e.GoodClinicalPractice(GCP)andInternationalConferenceofHarmonization(ICH)guidelines,SOPs.
?Provenabilitytomeetstrictdeadlines;managecompetingpriorities.
?Demonstrateeffectiveprojectmanagementandleadershipskills.
?Soundjudgment;independentthinkinganddecisionmakingskills.
?Demonstrateaflexibleandreceptiveapproachtochangingdemands.
?Provenabilitytoworkindependentlyandautonomouslywithpoliciesandpractices.
?Effectivementoringandcoachingskills.
?Excellentattentiontodetailandaccuracymaintainingconsistentlyhighqualitystandards.
?Excellentorganizationalskillsandtimemanagementskills.
?Excellentwritten/verbalcommunicationandreportwritingskills.
?Abilitytoestablishandmaintaineffectiveworkingrelationshipswithcoworkers,managersandclients.
?Abilitytoworkeffectivelyonmultipleprojectssimultaneouslyorganizeownworkloadandeffectivelymanagecompetingpriorities.
MINIMUMREQUIREDEDUCATIONANDEXPERIENCE
?Bachelor’sDegreeinaHealthScienceand3years’experienceofLifecyclesafety(Pharmacovigilance,CEVA,MedicalInformation,SafetyPublishing,RiskManagementetc)orequivalentcombinationofeducation,trainingandexperience..

其他要求

招聘人数：1人
职能类别：数据库建设

公司介绍

昆泰公司简介

昆泰是全球最大的生物制药服务企业（2011年净收入超过30亿美元），并且是全球范围内唯一一家可以提供全方位的临床、商业、咨询及投资解决方案的生物制药服务企业。昆泰公司覆盖80个国家，拥有达2.7万名员工。