Pharmacovigilance Manager (Abbott Nutrition Business)
Pharmacovigilance Manager (Abbott Nutrition Business)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
JOB DESCRIPTION:
Primary Function / Primary Goals /Objectives
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
ManagetheJapan PVteam(throughguidanceandsupervision)inthecollectionreviewandassessmentofadverseeventreports/safetyrelatedinformation
Ensuresubmissionofreportableadverseeventstothehealthauthorityinaccordancewithrequirementsandtimeframesoutlinedinlocalregulations
Developandmaintainlocalstandardoperatingproceduresthatarealignedwithcorporate/divisionlevelpoliciesandproceduresandfollowlocalregulationsDevelopandprovidePVtrainingfornew/juniorteammembersandlocalaffiliatestaff
ServeasthepointofcontactforalllocalPVactivitiesinquiriesandissuesincludingrespondingtoinquiriesfromthehealthauthority
PrepareandsubmitperiodicreportstothehealthauthorityincompliancewithlocalregulationsConductinternalinspectionsofthePVsystemasbylocalregulations
ServeasthePVleadduringinternalauditsandexternalinspections;prepareandexecuteCAPAsforanyPVrelatedfindings
Participateinthereviewofpromotionalmaterials
ActasthesafetydatabaseadministratorincludingcoordinatingmaintenanceandupgradesofthePV ITsystem
Managevendorandprocessassociatedwithsearchingofscientificliteratureforsafetyrelatedinformation
Participate/collaboratewiththeMedical Safety &Surveillanceteamonglobalsafety/pharmacovigilancerelatedinitiativesandgoals
SkillsandCompetencies
Functionsindependentlyasadecision-makerwithinspecifiedparametersanddecisionscouldpotentiallyhavefinancialramificationsorimpactbrandreputationregulatorycomplianceorpatientandproductsafety.Individualisrecognizedasaninternalsubjectmatterexpertandresourcewithresponsibilitiesthatrequirehighlevelcriticalthinkingandanalyticabilities.Leadscross-functionalprojectsrelatedtotheareaofexpertisewithahighlevelofvisibilityacrossthelocalaffiliatesite.ResponsibleforensuringcompliancewithlocalregulatoryrequirementsrelatedtopharmacovigilanceforJapansdrugproducts.
EducationRequired
Mastersdegreeinrelatedhealthsciencearea(pharmacyornutritiondesirable)orequivalentskillseducationorexperience
Experience / Knowledge /Certification
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
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Medical & Scientific Affairs
DIVISION:
ANRD Nutrition Research & Development
LOCATION:
Japan > Tokyo : Mita South Tower
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Manager
Employment Type
Full-Time
