Manager Global PV Aggregate Reporting

2 months ago

Mumbai, India Lifelancer Full time

Description

Kenvue is currently recruiting for:

Manager Global PV Aggregate Reporting

This position reports into the Associate Director Global PV Aggregate Reporting and Risk Management and is based in Mumbai or Pune India.

Who we are

AtKenvue we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science were the house of iconic brands including NEUTROGENA AVEENO TYLENOL LISTERINE JOHNSONS and BANDAID that you already know and love. Science is our passion; care is our talent. Our global team is made by 22000 diverse and brilliant people passionate about insights innovation and committed to deliver the best products to our customers. With expertise and empathy being a Kenvuer means to have the power to impact life of millions of people every day. We put people first care fiercely earn trust with science and solve with courage and have brilliant opportunities waiting for you Join us in shaping our futureand yours. For more informationclick here.

Role reports to:Associate Director Global PV Aggregate Reporting and Risk Management

Location:Mumbai or Pune India

Travel %:10

What you will do

The Manager Global Aggregate Reporting and Risk Management (GARRM) will be responsible for core safety deliverables including scheduled aggregate reports Risk Management Plans (RMPs) and Company Core Data Sheets (CCDS) and will serve as the report owner for assigned reports within Medical Safety for Kenvue products. The Manager is an aggregate reporting expert and will have indepth product knowledge to support daily activities including planning conducting meetings database searching aggregate safety analysis and case level review writing project management/coordination of strategic safety documents and oversight of deliverables produced by other team members. The Manager provides subject matter expertise and technical guidance on functional requirements and enhancements to meet emerging global regulatory requirements and implementation of global aggregate reporting solutions and training monitors compliance metrics and implements corrective and preventative actions to remediate nonconformance issues. She/he will partner with team members stakeholders including Global Risk Assessment and Safety Physicians (GRASPs) Qualified Person for Pharmacovigilance (QPPV) Product Vigilance and Safety System Oversight Signal Detection and Management (SDM) Global Case Management (GCM) Epidemiology Regulatory Affairs Clinical Medical Affairs Safety Science Analytics (SSA) Local Pharmacovigilance (LPV) and contracted vendor organizations.

Key Responsibilities

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

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

oProvide oversight of staff involved in aggregate reporting

oDevelop quality systems and procedures for the aggregate analysis and reporting of adverse effects related to Consumer products to assure regulatory compliance with company standards and regulatory requirements

oInitiate/Conduct/Oversee searches of internal and external databases

oPerform management review of all vendorproduced materials (e.g. draft reports and assessment responses); and/or lead aggregate safety analysis and case level review

oAuthor contribute and coordinate the preparation of core safety deliverables

oPrepares global aggregate reports for local authorities

oEnsure compliance (quality procedures regulations consistency) and commitments (e.g. Pharmacovigilance Agreements (PVAs) assessment reports) are met where applicable

oPartner with vendor to develop reports/deliverables

  • Develop and maintain global pharmacovigilance aggregate reporting processes and procedures in compliance with regulatory requirements
  • Lead and manage a team of pharmacovigilance professionals to ensure timely and accurate submission of aggregate reports
  • Collaborate with crossfunctional teams to ensure timely and accurate data collection and analysis for aggregate reporting
  • Stay uptodate with regulatory changes and industry trends related to pharmacovigilance aggregate reporting and implement necessary changes to processes and procedures
  • Develop and maintain systems tools and processes for drug safety operations
  • Participate and/or lead crossfunctional training of relevant stakeholders and colleagues
  • Act as product or process Subject Matter Expert (SME) during audits/inspections
  • Daily management of vendor activities and responsibility for compliance with SOPs/WIs global regulations/guidelines by either onsite or offshore resources
  • Performs training onboarding and oversight of offshore vendor
  • Participate or lead department and/or crossfunctional initiatives
  • Contributes metrics and ensures quality compliance and timeliness of aggregate safety reports

Qualifications

What we are looking for

Required Qualifications

  • Bachelors degree required (health/life sciences field)
  • 5 years of experience in the pharmaceutical or related industry with2 years of experience in Pharmacovigilance
  • Proven experience working in matrix environment and crossfunctional teams
  • Comprehensive clinical/medical writing experience
  • Strong English verbal and written communication skills
  • Strong knowledge of global pharmacovigilance regulations and guidelines (i.e. ICH GVP etc.)
  • Ability to work collaboratively with crossfunctional teams
  • Strong analytical and problemsolving skills.

Desired Qualifications

  • Advanced degree (e.g. MS MPH MSN PharmD RPh PhD etc.) preferred
  • Strong leadership and presentation skills
  • Experience in developing and implementing drug safety policies and operating procedures
  • Ability to work in a fastpaced environment and manage multiple projects simultaneously
  • SME with indepth product knowledge of assigned products; knowledge and handon experience in aggregate reports writing and compliance management
  • Indepth working knowledge of AE safety databases to identify system enhancements and efficiencies

Whats in it for you

  • Competitive Benefit Package*
  • Paid Company Holidays Paid Vacation Volunteer Time Summer Fridays More
  • Learning Development Opportunities
  • Employee Resource Groups
  • This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment hiring process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against on the basis of disability.

Primary LocationAsia PacificIndiaMaharashtraGreater MumbaiJob FunctionDrug Product Safety Operations


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