工作职责:
PositionPurpose
Overseesallaspectsofcreating,maintainingandimplementingacomprehensive,dynamicandresourceefficientcalendarofsafetydeliverables. Thisincludes,butisnotlimitedtoINDARs,DSURs,PADERs,PAERs,PSURs,SUSARLLsandapplicableadhocsafetyqueries. ThispositionnegotiatessafetysubmissioncommitmentswithPfizerCountryOfficesand/orRegulatory,ensuringcomplianceneedsaremetwhilebalancingresourceefforttocreatesubmissiondocuments;interactswithrequestorstoresolveadhocreportscheduling;andproposesassignments.
PrimaryResponsibilities
Createsandmaintainsthecomprehensivecalendarofsafetydeliverables.
Entersandassignsroutine,non-routineandadhocsafetydeliverables.
Negotiateswithappropriategroups(e.g.PCOs)toensurethataggregatereportcommitmentsaremet,whileminimizing,thenumberofindividualreportsrequired,whenpossible,aswellasdevelopingschedulesfornewaggregatereporttypesasrequiredbyregulations.
Participatesinappropriategovernanceandpolicymeetings/groups.Isempoweredtomakeindependentdecisionsaffectingtheoperationsofthegroup.
Actsassubjectmatterexpertonaggregatereportsschedulingandrepresentsthisroleonvariousteamsandtaskforces.
Actsasbusinesssubjectmatterexpertforsystemsusedforaggregatereportscalendar(DocFlow)andtheRMPassignment(Compass)andparticipatesinvarioustechnologyforums.
Designs,implements,andreportsrelevantaggregatereportingmetrics.
SupportsAudit/inspectionrequests.
MaintainsLicensePartneraggregatereportrequestsmailbox.
TechnicalSkillRequirements
Demonstratedabilitytolead/manageandbringprojectstosuccessfulcompletionwhilesimultaneouslyjugglingmultipleprojectsandprocessesthatspanglobally.
Generalknowledge/understandingoftechnologiesthatcansupportPfizer’ssafetysubmissionwork.AbilitytoadequatelyevaluateandleveragePfizer’ssystemintoimprovedbusinessprocessestosupportbusinessrequirements.
Comprehensiveworkingknowledgeofrequirementgathering,databasedesign,andreporting.
Knowledgeofclinicaldevelopmentand/orregulatorysubmissionprocessesandrequirements.Knowledgeofsafetysubmissionwork,e.g.aggregatereportingrequirementsandprocesses.
Effectiveoralandwrittencommunication.Demonstratedabilitytodesign,developanddelivereffectivepresentationstokeybusinessunits.
任职资格:
Qualifications(i.e.,preferrededucation,experience,attributes)
Scientific/technicalacademicbackgroundorequivalent,ideallywithexperienceinthepharmaceuticalindustry,regulatoryagency,orrelatedfield. Understandingofclinicaltrialsanddrugdevelopmentandcomprehensiveknowledgeoftheregulatoryenvironment.
AssociateManager
Basicknowledgeofsafetyandglobalregulatoryreportingregulationsandguidelines.
Strongprojectmanagementskillswithappropriatefollow-through
Developandrunrelevantaggregatereportingmetricsand/orreports
Preformsschedulingleadresponsibilitieswithguidance
Manager
Strongunderstandingofsafetyandglobalregulatoryreportingregulationsandguidelines.
ComprehensiveworkingknowledgeandunderstandingofITrequirementgathering,databasestructure,designandreportingtools.
Demonstratedabilitytomanageprojectssuccessfully,withminimalguidance.
Participatesinappropriategovernanceandpolicymeetings/groups
AssociateDirector
Stronginterpersonalskillswithdemonstratedabilitytobuildrelationshipsandinfluenceoutcomes.
Extensiveunderstandingofregulatory/safetyregulationsandguidelinesandcanindependentlyanswercomplexschedulingqueriesappropriately.
Strongprojectmanagementandissueresolutionskills.
Abletodelivereffectivepresentationstokeybusinessunits,asneeded.
Director
Leadsprojects/discussions.
Provenrecordinleadership,deliveringbusinesssolutionsandcustomerservice
Recommendsregulatoryreportingcoursesofactiontomanagement,asappropriate.
Acknowledgedasubjectmatterexpert.
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