Manager Global PV Aggregate Reporting

2 months ago

Mumbai, India Lifelancer Full time

Description

Kenvue iscurrently recruiting for:

ManagerGlobal PV Aggregate Reporting

This position reports into the Associate Director GlobalPV Aggregate Reporting and Risk Management and is based in Mumbaior Pune India.

Who weare

AtKenvue we realize theextraordinary power of everyday care. Built on over a century ofheritage and rooted in science were the house of iconic brandsincluding NEUTROGENA AVEENO TYLENOL LISTERINE JOHNSONS and BANDAIDthat you already know and love. Science is our passion; care is ourtalent. Our global team is made by 22000 diverse and brilliantpeople passionate about insights innovation and committed todeliver the best products to our customers. With expertise andempathy being a Kenvuer means to have the power to impact life ofmillions of people every day. We put people first care fiercelyearn trust with science and solve with courage and have brilliantopportunities waiting for you Join us in shaping our futureandyours. For more informationclick here.

Role reports to:AssociateDirector Global PV Aggregate Reporting and RiskManagement

Location:Mumbai or PuneIndia

Travel%:10

What you willdo

The Manager Global AggregateReporting and Risk Management (GARRM) will be responsible for coresafety deliverables including scheduled aggregate reports RiskManagement Plans (RMPs) and Company Core Data Sheets (CCDS) andwill serve as the report owner for assigned reports within MedicalSafety for Kenvue products. The Manager is an aggregate reportingexpert and will have indepth product knowledge to support dailyactivities including planning conducting meetings databasesearching aggregate safety analysis and case level review writingproject management/coordination of strategic safety documents andoversight of deliverables produced by other team members. TheManager provides subject matter expertise and technical guidance onfunctional requirements and enhancements to meet emerging globalregulatory requirements and implementation of global aggregatereporting solutions and training monitors compliance metrics andimplements corrective and preventative actions to remediatenonconformance issues. She/he will partner with team membersstakeholders including Global Risk Assessment and Safety Physicians(GRASPs) Qualified Person for Pharmacovigilance (QPPV) ProductVigilance and Safety System Oversight Signal Detection andManagement (SDM) Global Case Management (GCM) EpidemiologyRegulatory Affairs Clinical Medical Affairs Safety ScienceAnalytics (SSA) Local Pharmacovigilance (LPV) and contracted vendororganizations.

Key Responsibilities

  • Ensure timely quality reports/safety analysesrelated to core deliverables as appropriate:

oCollaborate with GRASP QPPV (where applicable) and otherstakeholders on strategy development

oProvideoversight of staff involved in aggregate reporting

oDevelop quality systems and procedures for the aggregateanalysis and reporting of adverse effects related to Consumerproducts to assure regulatory compliance with company standards andregulatory requirements

oInitiate/Conduct/Oversee searches of internal andexternal databases

oPerform management review ofall vendorproduced materials (e.g. draft reports and assessmentresponses); and/or lead aggregate safety analysis and case levelreview

oAuthor contribute and coordinate thepreparation of core safety deliverables

oPrepares global aggregate reports for localauthorities

oEnsure compliance (qualityprocedures regulations consistency) and commitments (e.g.Pharmacovigilance Agreements (PVAs) assessment reports) are metwhere applicable

oPartner with vendor to developreports/deliverables

  • Develop andmaintain global pharmacovigilance aggregate reporting processes andprocedures in compliance with regulatoryrequirements
  • Lead and manage a team ofpharmacovigilance professionals to ensure timely and accuratesubmission of aggregate reports
  • Collaboratewith crossfunctional teams to ensure timely and accurate datacollection and analysis for aggregatereporting
  • Stay uptodate with regulatory changesand industry trends related to pharmacovigilance aggregatereporting and implement necessary changes to processes andprocedures
  • Develop and maintain systems toolsand processes for drug safetyoperations
  • Participate and/or leadcrossfunctional training of relevant stakeholders andcolleagues
  • Act as product or process SubjectMatter Expert (SME) duringaudits/inspections
  • Daily management of vendoractivities and responsibility for compliance with SOPs/WIs globalregulations/guidelines by either onsite or offshoreresources
  • Performs training onboarding andoversight of offshore vendor
  • Participate orlead department and/or crossfunctionalinitiatives
  • Contributes metrics and ensuresquality compliance and timeliness of aggregate safetyreports

Qualifications

What we arelooking for

RequiredQualifications

  • Bachelors degreerequired (health/life sciences field)
  • 5 yearsof experience in the pharmaceutical or related industry with2 yearsof experience in Pharmacovigilance
  • Provenexperience working in matrix environment and crossfunctionalteams
  • Comprehensive clinical/medical writingexperience
  • Strong English verbal and writtencommunication skills
  • Strong knowledge of globalpharmacovigilance regulations and guidelines (i.e. ICH GVPetc.)
  • Ability to work collaboratively withcrossfunctional teams
  • Strong analytical andproblemsolving skills.

DesiredQualifications

  • Advanced degree (e.g.MS MPH MSN PharmD RPh PhD etc.)preferred
  • Strong leadership and presentationskills
  • Experience in developing andimplementing drug safety policies and operatingprocedures
  • Ability to work in a fastpacedenvironment and manage multiple projectssimultaneously
  • SME with indepth productknowledge of assigned products; knowledge and handon experience inaggregate reports writing and compliancemanagement
  • Indepth working knowledge of AEsafety databases to identify system enhancements andefficiencies

Whats init for you

  • CompetitiveBenefit Package*
  • Paid Company Holidays PaidVacation Volunteer Time Summer FridaysMore
  • Learning DevelopmentOpportunities
  • Employee ResourceGroups
  • This list could vary based onlocation/region

*Note: Total Rewardsat Kenvue include salary bonus (if applicable) and benefits. YourTalent Access Partner will be able to share more about our totalrewards offerings and the specific salary range for the relevantlocation(s) during the recruitment hiring process.

Kenvue is proud to be an Equal Opportunity Employer. Allqualified applicants will receive consideration for employmentwithout regard to race color religion sex sexual orientation genderidentity age national origin or protected veteran status and willnot be discriminated against on the basis of disability.

Primary LocationAsia PacificIndiaMaharashtraGreaterMumbaiJob FunctionDrug Product SafetyOperations


Lifelancer( ) is a talenthiring platform in Life Sciences Pharmaand IT. The platform connects talent with opportunities in pharmabiotech health sciences healthtech data science and ITdomains.

Please use the below Lifelancer linkfor job application and quickerresponse.

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