Kenvue is currently recruiting for:
Senior Scientist, GARRM Business Operations
This position reports into the Associate Director, GARRM Business Operations Lead and is based in Fort Washington, PA or Skillman, NJ USA.
Who we are
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 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 future-and yours. For more information, click here.
Role reports to: Associate Director, GARRM Business Operations Lead
Location: Fort Washington, PA or Skillman, NJ USA
Travel %: 10
Pay: (If compliant with country laws)
What you will do
The Senior (Sr.) Scientist, Global Aggregate Reporting and Risk Management (GARRM) Business Operations supports the Associate Director, GARRM Business Operations Lead in all operational activities associated with the aggregate reports, Risk Management Plans (RMPs), Ad Hoc Safety Reports (AHSRs), and Company Core Data Sheet (CCDSs) within Medical Safety for Kenvue products. She/He will be responsible for the day-to-day management of operations for GARRM and the oversight of end-to-end offshore vendor operations. She/He will support overseeing of compliance, quality, procedures, pharmacovigilance (PV) systems, training, timeliness, scheduling, and consistency all reports produced by GARRM. She/He has the proven ability to provide operational direction to a global staff of employees, contractors, and/or vendors.
The Sr. Scientist GARRM Business Operations is also responsible for core safety deliverables including scheduled aggregate reports and may serve as the report owner for assigned reports. She/He will support or lead cross-functional teams to develop and promote best practices, processes, identify new tools, and develop new systems and policies to promote consistent aggregate reports excellence and monitor performance trends and drive continue process improvements related to aggregate reports.
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
• Oversee (direct, train, motivate, evaluate) end-to-end offshore vendor operations. This includes management of vendor activities including:
o Sponsorship
o Onboarding and training
o Ensure compliance with SOPs/WIs, global regulations/guidelines
o Ensure compliance to vendor Service Level Agreements
o Review and/or approval of contracts and invoices
o Develop and coordinate processes for offshore vendor
o Monitor performance trends and drive continue process improvements related to aggregate reports
• Training/Meetings:
o Ensures assignment of relevant trainings and compliance to trainings for onsite or offshore resources
o Participate in cross-functional training of relevant stakeholders
o Trains self, employees, and contractors on the PV responsibilities prior to work engagements; updates training of self and others as required in compliance with schedules and regulations
• Ensure timely, quality reports/safety analyses related to core deliverables as appropriate:
o Collaborate with GRASP, QPPV (where applicable), and other stakeholders on strategy development
o Provide oversight of staff involved in aggregate reporting
o Develop 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
o Initiate/Conduct/Oversee searches of internal and external databases
o Perform management review of all vendor-produced materials (e.g. draft reports and assessment responses); and/or lead aggregate safety analysis and case level review
o Author, contribute, and coordinate the preparation of core safety deliverables
o Prepares global aggregate reports for local authorities
o Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable
o Partner with vendor to develop reports/deliverables
• Develop, implement, and support policies, SOPs, tools, PV systems etc., pertaining to scheduled aggregate safety reports, RMPs, AHSRs, and CCDSs.
• Participate or lead department and/or cross-functional initiatives and projects.
• Support GARRM inspection readiness activities and support internal audits, and Regulatory Authority inspections.
What we are looking for
Required Qualifications
• Bachelor's degree required (health/life sciences field preferred)
• ≥3 years of experience in the pharmaceutical or related industry with ≥2 years of experience in Pharmacovigilance
• Proven experience working in matrix environment with cross-functional teams
• Comprehensive clinical/medical writing experience
• Strong English verbal and written communication skills
• Strong analytical and problem-solving skills
• Ability to work in a fast-paced environment and manage multiple projects simultaneously
Desired Qualifications
• Advanced degree (e.g., MS, MPH, MSN, PharmD, RPh, PhD, etc.) preferred
• Strong leadership and presentation skills
• Project management experience
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
• 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.
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