安全协调员工作职责
岗位职责：
1.PreparestherespectivesubmissiondocumentstoHealthAuthorities
2.SupervisionofproperflowofconfirmationsofreceiptofdocumentationsenttotheHealthAuthorities.
3.PreparationandeverydaydistributionofrespectivePatientSafetydocuments.
4.Participationintheverificationprocessofdatacorrectnessintheglobalsafetydatabase.
5.VerificationofcorrectnessandcomplianceofdocumentationsenttoPatientSafetyDepartment
6.PreparationofthePatientSafetytrainingmaterials(incl.confirmations)andlogisticorganizationofthesetrainings
·Editing(whererequiredandasperrequestfromPatientSafetyMember)trainingmaterials
·Preparationofconfirmations,certificates,printingoftrainingmaterialsforparticipants
7.Archivingallsafetydocumentationasperrespectivepolicies,guidanceandprocedures.
8.VerificationandupdateofrespectivePSarchivingsystem(incl.review,update,management)
9.MonitoringofthecompliancewithsupportofPSAssociate
10.Managecollection,processing,documentation,reportingandfollow-upofalladverseeventsreportsforallNovartisgroupproductsfromclinicaltrials,non-interventionalstudies,PatientOrientedPrograms,literature,SpontaneousReports,etc.
11.Recordandtrackreceipts,submissionsanddistributionsofSAEs,SRs,SuspectedUnexpectedSeriousAdverseReaction(SUSAR).
12.Managereporting/submission/distributionofsafetyreports/updates/information(e.g.SAE,SR)toLocalHealthAuthorities(LHA)and/orclinicaloperations.
13.Workwithotherlocal/globalPSassociatestoensureaccurateevaluationofsafetydata.
14.InteractandexchangerelevantsafetyinformationwithLHA,PSassociates,otherfunctionalgroupsandthirdpartycontractor,ifapplicable.
15.SurveyandmonitornationalpharmacovigilanceregulationsandprovideupdatetoglobalPSorganization.
16.Supportindeveloping,updatingandimplementinglocalprocedurestoensurecompliancewithPSglobalproceduresandnationalrequirements.
17.Input,reviewandapprovalofprogramproposalsforlanguage,contentandestablishmentofnecessarycontrolsoncollectionandreportingofadverseeventinformation.
18.Performreconciliationwithotherdepartments(e.g.MedicalInformation,QualityAssuranceandthirdpartycontractor,ifapplicable)forpotentialAEsresultingfrommedicalinquiries,qualityrelatedcomplaintsandothersources.
19.ManagementandmaintenanceofallrelevantPSdatabases.
20.PrepareandsubmitKPIreportsoncomplianceinatimelymannerincludingidentificationofrootcause(s)forlatereportingtoLHA,developmentandimplementationofcorrectiveaction(s)asneeded.
*deletewhennotneeded/notappropriate,ormodifyasperlocalactivities.
任职要求：
·FluentinbothwrittenandspokenEnglish
·Fluentinbothwrittenandspokenlocallanguage
·Experienceonsimilarpositionindrugsafetyordrugregistrationorclinicalresearchdepartmentwouldbeanadditionalasset.
·Provenabilitytoworkincross-functionalteams
·Computerskills(e.g.Excel,Word,PowerPoint)andabilitytolearnnewsystemsquickly.
招聘安全协调员的工资一般是多少
哈尔滨生产计划协调员 ￥3750元
福州生产协调员 ￥2500元
大连项目协调员 ￥6950元
泉州临床协调员crc ￥6250元
临床协调员crc ￥6280元
临床协调员 ￥6170元
项目协调员 ￥7330元
销售协调员 ￥3630元
上海临床协调员 ￥7750元
协调员 ￥5910元
