WHAT WE DO

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.

WHO WE ARE

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact 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.

WHAT YOU WILL DO

The Area Safety Lead (United States) is responsible for ensuring that the local operating company (LOC) safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.
This role will act as the Local Operating Company (LOC)’s and assigned territories (as applicable) point of contact for pharmacovigilance matters with the local health authority. They will ensure that appropriate product vigilance and risk management systems are set in place to assure appropriate oversight of products within its responsibility.

KEY RESPONSIBILITIES

• Maintain up to date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborate with global team to implement process changes required for identification of new requirements
• Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.
• Record self-identified non-conformances and collaborate with the global team to investigate non-conformances while developing and implementing effective CAPAs.
• Provide oversight of vendor resources in the countries in scope.
• Act as a delegate for the Area Safety Head, when required.
• Maintain local procedures where applicable and assessing the impact of changes for the global procedure to local procedures.
• Management of PV clauses to be included within local agreements.
• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Maintain oversight of proper identification of local literature articles for AE reporting as required.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Ensure reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders) is performed.
• Collaborating with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.
• Collaborate with the local and global teams to ensure pharmacovigilance compliance of local company sponsored programs and research activities.
• Perform document management and archiving as required.
• Provide technical and strategic input and participate in projects/ workstreams led by the Kenvue Medical Safety teams or LOC.