Kenvue is currently recruiting for Manager, Global Aggregate Reporting and Risk Management (GARRM]. This position reports into Director of Global PV Agg Report and Risk Management and is based at located in Fort Washington, PA or Skillman, NJ., and has the flexibility to work remotely, as needed.

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.

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What will you do

The Manager GARRM will be part of the global Kenvue Medical Safety (KMS) Team and will work closely with global cross-functional groups within and outside of KMS. They 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.

Key Responsibilities:

• Responsibility for compliance with standard operating procedures (SOPs), global regulations/guidelines, corporate policies, and timelines.
• Support daily aggregate report 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 vendor team members.
• Build working partnerships and relationships with cross-functional groups within and outside KMS, including Medical Safety Officers (MSOs), Qualified Person for Pharmacovigilance (QPPV) and delegates, Global Case Management, Epidemiology, Regulatory Affairs, Clinical and Medical Affairs, Local Safety Officers (LSOs), and contracted vendor organizations.
• 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 cross-functional projects and initiatives.

What we are looking for

Required Qualifications

• Bachelor's degree in life-sciences or health-care field with >3 years of experience in Pharmacovigilance (PV) or related industry.

OR

• Advanced degree (e.g., MS, MPH, PharmD, or PhD) with >2 years of experience in PV or related industry.
• Excellent English verbal and written communication skills
• Ability to plan work to meet deadlines and effectively balance multiple priorities
• Proven experience working in matrix environment and cross-functional 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.)
• Up to 10% travel (domestic and international) required.

Desired Qualifications

• Solid understanding of medical concepts and familiarity with safety activities in drug development and post-marketing and global safety health authority requirements.
• Experience working with global safety databases, including case management and comprehensive data analysis.
• Third-party vendor oversight
• Author and/or process owner of controlled procedural documents (i.e., SOPs, WIs, etc.)
• Inspection and audit support, including readiness activities

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 $111,000 to $192,000.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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 identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.