美资CRO药物安全/警戒（高级）专员社

10K-15K/月

上海市

发布时间：2023-09-06

职位描述

职位描述：

PURPOSE
Review,assessandprocessLifecycleSafetydataandinformation,acrossallservicelinesreceivedfromvarioussourcesanddistributereports/dataonwardstobothinternalandexternalthirdpartiesfollowingapplicableregulationsSOP’sandinternalguidelines.Mayprovideoversightonprojectswithlimitedcomplexitiesforactivitiesonsmalltomediumserviceoperationalprojects.

RESPONSIBILITIES

？Receive,triage,reviewandprocessLifecycleSafetydatafromvarioussourcesontime,withinbudgetandqualitystandards.PerformdataentryfortrackingandLifecycleSafetydatabases,codingrelevantmedicalterminology,writingdescriptnarratives,generatingqueriespertinenttothecase,performingqualitycontrol,assistingwithreconciliation,drivingcaseclosure,coordinatingtranslationsandensuringreportsaresenttothecustomerwithinassigneddeadlines.Pre-processmaterialforendpointcommitteeorcorelaboratoryadjudication.Preparationofmaterialforsubmissionofsecondaryreview.
？AssessLifecycleSafetydataforreportabilitytorelevantauthorities,trackreportablecasesandreporttoregulatoryauthorities,ethicscommittees,institutionalreviewboards,investigators,oversightgroupsperlegislation,withintimelinesandinaformatcompatibletorequirement.LiaisewithlocalQuintilesofficestofacilitateexpeditedreporting.Liaisewithsystemsmanagerforregulatorytrackingrequirementsandelectronicreporting.
？ContributetoindividualdeliverablesinthefieldofSafetyPublishing,RiskManagement,SafetySurveillanceandMedicalInformationorotherservicelinesasappropriate.
？Receiveanddocumentincomingtelephonecalls,faxesoremailsfrominvestigativesitesorothersourcesreportingLifecycleSafetydata.
？ProcessLifecycleSafetydataaccordingtoapplicableregulations,guidelines,StandardOperatingProcedures(SOPs)andprojectrequirements.
？Mentoringlessexperiencedornewerstaffmembers.Mayprovideoversightonoperationalactivitiesandhaveasoundunderstandingofprojectprotocol,therapeuticindication,budgetandscopeofwork(SOW)forassignedprojects;setupandmaintainprojectfiles,standards,templates,electronicforums,databasesandworkflow.
？MayprovideoversightroletoimparttechnicalandprocessinformationtotheLSMpointofcontactandmembersofoperationalteam.
？MayprovideanoversightroletoperformoperationalandcollaborativeLSMtasksasdirectedbyLifecycleSafetyInfrastructure.
？Participateinteammeetingsandprovideregularfeedbacktooperationsteammanagerandlifecyclesafetymanagement(LSM)onoperationalprojectmetrics,outofscopeworkchallenges/issuesandsuccesses.
？EnsurecompliancetoQuintileshighqualitystandardsandworkswithLSMconstructivelyinamatrixframeworktoachieveprojectandcustomerdeliverables.
？WorkwithLSMconstructivelyinamatrixframeworktoachieveprojectandcustomerdeliverables.
？ParticipateintrainingacrossLifecycleSafetyserviceofferings.Provideproject-specificoperationalprocesstrainingtojuniorteammembers,monitorsandinvestigativesitepersonnel,asappropriate.
？Liaisewithdifferentfunctionalteammembers,e.g.projectmanagement,clinical,datamanagement,healthcareprofessionalse.g.investigators,medicalmonitors,sitecoordinatorsanddesigneestoaddressoperationalprojectissues.
？Contributetoachievementofdepartmentalgoalse.g.utilizationrealizationandproductivitymetrics.
？ReadandacknowledgeallnecessaryQuintilesstandardoperatingprocedures(SOPs)andcustomerSOPsasrequired.Ensureallrequiredtrainingisexecutedinatimelyfashionanddocumented.Worktowardsensuringyourindividualtrainingplanandtrainingtranscriptarereconcilable.
？Performotherdutiesasassigned.
JOBDESCRIPTION

REQUIREDKNOWLEDGE,SKILLSANDABILITIES
？ExcellentknowledgeofLifecycleSafetyprocesses;willingnessandaptitudetolearnnewskillsacrossLifecycleSafetyservicelines.
？Goodunderstandingofapplicableglobal,regional,localclinicalresearchregulatoryrequirements;i.e.GoodClinicalPractice(GCP)andInternationalConferenceofHarmonization(ICH)guidelines,StandardOperatingprocedures(SOPs)
？Provenabilitytomeetstrictdeadlines;managecompetingprioritiesandchangingdemands.
？Provenabilitytofollowinstructions/guidelines,workindependentlyandonowninitiative.
？Goodunderstandingofoperationalmetrics,productivityandinitiatives.
？Excellentattentiontodetailandaccuracyandmaintainconsistentlyhighqualitystandards.
？Effectivementoringskills.
？Excellentwrittenandverbalcommunicationandreportwritingskills.
？Abilitytobeflexibleandreceptivetochangingprocessdemands.
？Soundjudgment;decisionmakingskills.
？Abilitytoworkeffectivelyonmultipleprojectssimultaneously.Organizeownworkloadandeffectivelytimemanagecompetingpriorities.
？Abilitytoestablishandmaintaineffectiveworkingrelationshipswithcoworkers,managersandclients.
MINIMUMREQUIREDEDUCATIONANDEXPERIENCE
？Bachelor’sDegreeoreducationalequivalentinaScientificorHealthcaredisciplineand1year’sexperienceofLifecycleSafety(Pharmacovigilance,CEVA,MedicalInformation,SafetyPublishing,RiskManagementetc)orequivalentcombinationofeducation,training.

PHYSICALREQUIREMENTS
？Extensiveuseofkeyboardrequiringrepetitivemotionoffingers.
？Extensiveuseoftelephoneandface-to-facecommunicationrequiringaccurateperceptionofspeech.
？Regularsittingforextendedperiodsoftime.
？Mayrequireoccasionaltravel.

其他要求

招聘人数：1人
职能类别：生物工程

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。