药品注册专员岗位胜任力评价指标体系的构建郭建飞韩晟陈敬史录文F272.92;R95文献标志码A1001-0408（2021）09-1045-06DOI10.6039/j.issn.1001-0408.2021.09.04摘要目的：构建科学客观的药品注册专员岗位胜任力评价指标体系。方法：通过查找药品注册胜任力模型文献、注册相关法规性文件，结合Spencer胜任力辞典和Hay胜任力辞典，初步拟定药品注册专员岗位胜任力评价指标体系。通过两轮德尔菲专家咨询法对药品注册相关领域专家进行函询，筛选与修正评价指标，并运用优序图法对指标进行權重计算;基于问卷调查法，以232名药品注册工作的相关人员为研究对象，再运用探索性因子分析、验证性因子分析和信度分析对构建的评价指标体系进行检验。结果：构建的药品注册专员岗位胜任力评价体系涵盖4个核心维度（注册专业能力、关系管理能力、专业发展能力、个人综合素质）、11个子维度、41个测量条目，并确定了各维度指标权重。该评价体系建立过程中专家积极性高、协调性好，探索性因子分析和验证性因子分析证明了该指标体系的科学合理性。结论：所建药品注册专员岗位胜任力评价指标体系具有全面性、综合性、科学性，可为药品注册专员的评价和管理提供依据。关键词药品注册专员;胜任力;德尔菲专家咨询;评价指标体系ConstructionofPostCompetencyEvaluationIndexSystemforDrugRegistrationSpecialistGUOJianfei1，HANSheng2，CHENJing1，SHILuwen1，2（1.Dept.ofPharmacueticalAdministrationandClinicalPharmacy，CollgeofPharmacy，PekingUniversity，Beijing100191，China;2.InternationalResearchCenterforPharmaceuticalAdministration，PekingUniverstiy，Beijing100191，China）ABSTRACTOBJECTIVE：Toestablishascientificandobjectivepostcompetencyevaluationindexsystemforthedrugregistrationspecialist.METHODS：Bysearchingthecompetencymodelliteratureofdrugregistrationandregistrationrelateddocuments，combinedwithSpencersCompetencyDictionaryandHaysCompetencyDictionary，postcompetencyevaluationindexsystemfordrugregistrationspecialistwasformulatedpreliminarily.ThroughtworoundsofDelphiexpertconsultation，expertsinrelatedfieldsofdrugregistrationwereconsultedbyletter，theevaluationindexeswerescrennedandrevised，andtheweightoftheindexeswascalculatedbyusingthesuperiororderdiagrammethod.Basedonquestionnairesurvey，232drugregistrationpersonnelwereselectedasresearchobjects，andthenexploratoryfactoranalysis，confirmatoryfactoranalysisandinternalconsistencyreliabilityanalysiswereusedtotesttheconstructedevaluationindexsystem.RESULTS：Thepostcompetencyevaluationsystemofdrugregistrationspecialistcovered4coredimensions（registeredprofessionalability，relationshipmanagementability，professionaldevelopmentability，personalcomprehensivequality），11sub-scales，and41measurementitems;theweightoftheindexwasconfirmed.Theestablishmentprocessoftheevaluationsystemshowedthattheexpertconsultationhadhighenthusiasmandgoodcoordination;exploratoryfactoranalysisandconfirmatoryfactoranalysishadprovedthescientificrationalityoftheindexsystem.CONCLUSIONS：Thepostcompetencyevaluationindexsystemfordrugregistrationspecialistiscomprehensive，integratedandscientific，canprovidereferenceforevaluationandmanagementofthedrugregistrationspecialistpractice.KEYWORDSDrugregistrationspecialist;Competency;Delphiconsultation;Evaluationindexsystem世界卫生组织在“药品”的定义中指出：药品不是普通的商品，其要满足人类健康的基本需求，而实行药品监管和注册的主要目的也是为了确保人类的健康[1]。药品注册专员的责任是在确保公司的产品满足监管机构所有法律法规要求的前提下，推动产品上市销售[2]。《北京市药品注册专员登记办法》对“药品注册专员”给出的官方定义是：熟悉药品注册的管理法...