Associate Director, Global Aggregate Reporting and - Jersey, United Kingdom - Kenvue

Kenvue
Kenvue
Verified Company
Jersey, United Kingdom

3 weeks ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter


Description

Associate Director, Global Aggregate Reporting and Risk Management (GARRM) Self-Care Stronghold Lead W

Description

Kenvue is currently recruiting for Associate Director (AD), Global Aggregate Reporting and Risk Management (GARRM) Self-Care Stronghold Lead.

This position reports into Director of Global PV Agg Report and Risk Management and Global Product Safety, and is based at located in the Fort Washington, PA or Skillman, NJ, United Kingdom (UK) or hybrid remote(2 to 3 days in the office required).


Who We Are


At Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), we believe there is extraordinary power in everyday care.

Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID —are category leaders trusted by millions of consumers who use our products to improve their daily lives.

Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers' hearts and homes.

Join us in shaping our future-and yours.


Watch us here:


The AD GARRM Self-Care Stronghold Lead will be part of the global Office of Consumer Medical Safety (OCMS) Team and will work closely with global cross-functional groups within and outside the OCMS.

They will be responsible for the day-to-day management and oversight of the GARRM Self-Care Team, including end-to-end off-shore vendor operations.

They will oversee compliance, quality, procedures, regulations, timeliness, and consistency of scheduled aggregate reports, Risk Management Plans (RMP) and Company Core Data Sheet (CCDS) for Consumer Self-Care products.

They should have the proven ability to provide technical as well as managerial leadership to a global staff of employees, contractors, and vendors.


Responsibilities:


  • Daily management of staff activities and responsibility for compliance with standard operating procedures (SOPs), global regulations/guidelines, corporate policies, and timelines.
  • Lead a global team of employees and vendors, including management of resource needs, workload allocation, talent development, and performance evaluation.
  • Build working partnerships and relationships with crossfunctional groups within and outside OCMS.
  • Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable.
  • Act as product or process Subject Matter Expert (SME) during audits/inspections.
  • Monitor performance trends and drive continue process improvements related to aggregate reports.
  • Participate in or lead functional, departmental and/or crossfunctional projects and initiatives.
Qualifications


Qualifications

Required:


  • Bachelor's degree in lifesciences or healthcare field
  • 5 years of experience in Pharmacovigilance or related industry required; advanced degree (e.g., MS, MPH, PharmD, or PhD)
  • Ability to plan work to meet deadlines and effectively balance multiple priorities
  • Proven experience working in matrix environment and crossfunctional teams
  • Development of aggregate safety reports (e.g., PBRER/PSUR, PADER, DSUR)
  • Working knowledge of applicable global and regional regulatory requirements (i.e., ICH guidelines, GVP, etc.)
  • Thirdparty vendor oversight
  • Author and/or process owner of controlled procedural documents (i.e., SOPs, WIs, etc.)
  • Inspection and audit support, including readiness activities
  • CAPA management, including rootcause analysis and effectiveness checks

Preferred:


  • Excellent English verbal and written communication skills
  • Direct people management experience, including performance and development planning/evaluation and talent development.
  • Working knowledge of medical concepts and familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
  • Experience working with global safety databases, including case management and comprehensive data analysis.
  • Up to 10% travel (domestic and international) required.
What's in it for you

  • Competitive Benefit Package
  • Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More
  • Learning & Development Opportunities
  • Employee Resource Groups
The anticipated base pay range for this position is $131,000 to $225,000.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies.

Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success.

We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive c

More jobs from Kenvue