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外资制药岗位职责
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药物警戒经理-外资制药Responsiblefortheline-managementofindividualswithinateamaswellasaprojectteam.
Managedirectreportstoensurestafftrainingrecordsareuptodate.
Responsibleformanagingperformancereviewsandissuesofdirectreports.
Maymanageindividualsacrossmultipleteamsandwilltakeonresponsibilityforcrossdepartmentprojects.
Responsibleforofficemanagement(schedules,deskassignments,businesscontinuityplanning,disasterrecovery,etc.).
MayleadorassistwiththemanagementofPV&DSSconcerningprojectallocationandresourcing.
Generaloversightforthereceiptandprocessingofalladverseeventreportsreportedeitherspontaneouslyfromanysourceorfromaclinicaltrial.Thisincludes,butnotlimitedto:
Entryofsafetydataontoadverseeventtrackingsystems
Reviewofadverseeventsforcompleteness,accuracyandappropriatenessforexpeditedreporting
Writepatientnarratives
CodeadverseeventsaccuratelyusingMedDRA
Determineexpectedness/listednessagainstappropriatelabel
Identifiesclinicallysignificantinformationmissingfrominitialreportsandensuresitscollection
Ensurecasesreceiveappropriatemedicalreview
Preparefollow-upcorrespondenceconsultingwiththemedicalstaffaccordingly
Ensureallcasesthatrequireexpeditingreportingtoworldwideregulatoryagenciesareprocessedswiftlyandappropriatelywithinrequiredtimelines
Reportingofendpointstoclients,regulatoryauthorities,ethicscommittees,investigatorsandCovanceprojectpersonnel,ifrequired,withinstudyspecifiedtimelines
Generaloversightforthemanagementandprocessingofexpeditablesafetyreports(ESRs).Thisincludes,butisnotlimitedto:
Reviewandupdateadverseeventdatabasesandtrackingsystems
Reviewofadverseeventsforcompleteness,accuracyandappropriatenessforESR
Reviewofpatientnarratives
Reviewthecodingofadverseevents
ReviewofreportingofESRsandendpointstoclients,regulatoryauthorities,ethicscommittees,investigatorsandCovanceprojectpersonnel,ifrequired,withinstudyspecifiedtimelines
Completetriage,distributionchecklistandqualityreviewofallESRforassignedprojects.
ExecuteroutinequalityreviewofAEreportsandaggregatereportsforothermembersofthegroupensuringthatcaseprocessinganddataqualitymeetglobalregulatorycomplianceneedsincludingauditsupport.
MaintainawarenessofCovance’ssafetydatabaseconventionsandsystemfunctionality.
Maintainawarenessofotherclientsafetydatabaseconventionsandfunctionality.
Mayprepare,butdefinitelyprovideoversighttothetimelypreparationofpharmacovigilancereportsforproductsandsafetyissues,includingIndividualCaseSummaryReports(ICSR)ofSeriousAdverseEvents(SAEs)andaggregatereportingResponsibleforthetimelypreparationandreviewofSafetyManagementPlans(SMPs),ReconciliationPlans,andothersafety-specificplansensuringoptimalefficiency.
ProvideoversightandmanagementofEudraVigilanceactivitiesforassignedprojects.
Provideoversightand/orperformsignaldetectionandtrendandpatternrecognitionactivities,asrequiredforassignedprojects.
ContributetothegenerationandreviewofTimeandCostEstimatesforPV&DSSbusiness.
WorkcloselywiththeclinicaloperationsandprojectmanagementgroupstoensurealldrugResponsiblefortheline-managementofindividualswithinateamaswellasaprojectteam.
Managedirectreportstoensurestafftrainingrecordsareuptodate.
Responsibleformanagingperformancereviewsandissuesofdirectreports.
Maymanageindividualsacrossmultipleteamsandwilltakeonresponsibilityforcrossdepartmentprojects.
Responsibleforofficemanagement(schedules,deskassignments,businesscontinuityplanning,disasterrecovery,etc.).
MayleadorassistwiththemanagementofPV&DSSconcerningprojectallocationandresourcing.
Generaloversightforthereceiptandprocessingofalladverseeventreportsreportedeitherspontaneouslyfromanysourceorfromaclinicaltrial.Thisincludes,butnotlimitedto:
Entryofsafetydataontoadverseeventtrackingsystems
Reviewofadverseeventsforcompleteness,accuracyandappropriatenessforexpeditedreporting
Writepatientnarratives
CodeadverseeventsaccuratelyusingMedDRA
Determineexpectedness/listednessagainstappropriatelabel
Identifiesclinicallysignificantinformationmissingfrominitialreportsandensuresitscollection
Ensurecasesreceiveappropriatemedicalreview
Preparefollow-upcorrespondenceconsultingwiththemedicalstaffaccordingly
Ensureallcasesthatrequireexpeditingreportingtoworldwideregulatoryagenciesareprocessedswiftlyandappropriatelywithinrequiredtimelines
Reportingofendpointstoclients,regulatoryauthorities,ethicscommittees,investigatorsandCovanceprojectpersonnel,ifrequired,withinstudyspecifiedtimelines
Generaloversightforthemanagementandprocessingofexpeditablesafetyreports(ESRs).Thisincludes,butisnotlimitedto:
Reviewandupdateadverseeventdatabasesandtrackingsystems
Reviewofadverseeventsforcompleteness,accuracyandappropriatenessforESR
Reviewofpatientnarratives
Reviewthecodingofadverseevents
ReviewofreportingofESRsandendpointstoclients,regulatoryauthorities,ethicscommittees,investigatorsandCovanceprojectpersonnel,ifrequired,withinstudyspecifiedtimelines
Completetriage,distributionchecklistandqualityreviewofallESRforassignedprojects.
ExecuteroutinequalityreviewofAEreportsandaggregatereportsforothermembersofthegroupensuringthatcaseprocessinganddataqualitymeetglobalregulatorycomplianceneedsincludingauditsupport.
MaintainawarenessofCovance’ssafetydatabaseconventionsandsystemfunctionality.
Maintainawarenessofotherclientsafetydatabaseconventionsandfunctionality.
Mayprepare,butdefinitelyprovideoversighttothetimelypreparationofpharmacovigilancereportsforproductsandsafetyissues,includingIndividualCaseSummaryReports(ICSR)ofSeriousAdverseEvents(SAEs)andaggregatereportingResponsibleforthetimelypreparationandreviewofSafetyManagementPlans(SMPs),ReconciliationPlans,andothersafety-specificplansensuringoptimalefficiency.
ProvideoversightandmanagementofEudraVigilanceactivitiesforassignedprojects.
Provideoversightand/orperformsignaldetectionandtrendandpatternrecognitionactivities,asrequiredforassignedprojects.
ContributetothegenerationandreviewofTimeandCostEstimatesforPV&DSSbusiness.
Workcloselywiththeclinicaloperationsandprojectmanagementgroupstoensurealldrug
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