**Primary Function / Primary Goals /** **Objectives（主な役割／目標／目的** **）** + Manage the collection, processing and assessment of safety related information as it relates to Abbott Nutrition products in compliance with applicable regulatory requirements and guidelines, as well as division and corporate level policies and procedures; Ensure the pharmacovigilance (PV) system for Abbott Nutrition products registered as drugs in Japan is in place and is compliant with regulatory standards; Maintain the PV IT system used for adverse event reporting. The manager is considered a subject matter expert in the area of pharmacovigilance. **Core Job Responsibilities / Accountability /** **Scope（主な職務／責任／範囲** **）** + ManagetheJapan PVteam(throughguidanceandsupervision)inthecollection,review,andassessmentofadverseeventreports/safetyrelatedinformation• + Ensuresubmissionofreportableadverseeventstothehealthauthorityinaccordancewithrequirementsandtimeframesoutlinedinlocalregulations + Developandmaintainlocalstandardoperatingproceduresthatarealignedwithcorporate/divisionlevelpoliciesandproceduresandfollowlocalregulations•DevelopandprovidePVtrainingfornew/juniorteammembersandlocalaffiliatestaff + ServeasthepointofcontactforalllocalPVactivities,inquiriesandissues,includingrespondingtoinquiriesfromthehealthauthority + Prepareandsubmitperiodicreportstothehealthauthorityincompliancewithlocalregulations•ConductinternalinspectionsofthePVsystemasrequiredbylocalregulations + ServeasthePVleadduringinternalauditsandexternalinspections;prepareandexecuteCAPAsforanyPVrelatedfindings + Participateinthereviewofpromotionalmaterials + Actasthesafetydatabaseadministrator,includingcoordinatingmaintenanceandupgradesofthePV ITsystem + Managevendorandprocessassociatedwithsearchingofscientificliteratureforsafetyrelatedinformation + Participate/collaboratewiththeMedical Safety &Surveillanceteamonglobalsafety/pharmacovigilancerelatedinitiativesandgoals **Required** **Skills** **and** **Competencies（必要とされるスキルおよびコンピテンシ** **ー）** + Functionsindependentlyasadecision-makerwithinspecifiedparametersanddecisionscouldpotentiallyhavefinancialramificationsorimpactbrandreputation,regulatorycompliance,orpatientandproductsafety.Individualisrecognizedasaninternalsubjectmatterexpertandresourcewithresponsibilitiesthatrequirehighlevelcriticalthinkingandanalyticabilities.Leadscross-functionalprojectsrelatedtotheareaofexpertisewithahighlevelofvisibilityacrossthelocalaffiliatesite.ResponsibleforensuringcompliancewithlocalregulatoryrequirementsrelatedtopharmacovigilanceforJapan’sdrugproducts. **Education** **Required（必要とされる知識および教育レベル** **）** + Master'sdegreeinrelatedhealthsciencearea(pharmacyornutritiondesirable)orequivalentskills,educationorexperience **Experience / Knowledge /** **Certification（必要とされる経験・知識・資格** **）** • 7+ years of experience working in pharmacovigilance for drug or nutritional products • Sound knowledge of local (Japan) nutritional/pharmacovigilance regulations • Experience managing direct reports and leading complex projects related to pharmacovigilance/product safety • Fluency in spoken/written Japanese and English • Computer proficient (Windows, Word, Excel); experience working in adverse event/safety databases • Excellent communication and interpersonal skills, both written and spoken • Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects • Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com