<p>Kenvue is currently recruiting for:</p> <p>Head of Global Risk Assessment</p> <p>This position reports to QPPV Head of Safety Science and Policy and is based at Summit, NJ. Kenvue is currently in the process of moving its Global Headquarters from Skillman, NJ to Summit, NJ. This role is based in Summit, NJ but there may be a period of time during the transition that you must report to Skillman, NJ.</p> <p>Who we are</p> <p>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 Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the 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.</p> <p>Role reports to: QPPV Head of Safety Science and Policy</p> <p>Location: Kenvue is currently in the process of moving its Global Headquarters from Skillman, NJ to Summit, NJ. This role is based in Summit, NJ but there may be a period of time during the transition that you must report to Skillman, NJ.</p> <p>Travel %: 5%</p> <p>Pay: $238,000 - $322,000</p> <p>What you will do</p> <p>The QPPV Head of Safety Science and Policy is responsible for provides strategic thought leadership on frameworks that determine evaluation and communication of safety signals, safety concerns or insights and risk mitigation strategies, and shall ensure that performed activities fulfill the relevant regulatory requirements and all applicable Kenvue processes. The Director communicates potential and known concerns/risks, their assessment and need for risk mitigation to the direct management, Regional Medical Safety Officers, the Qualified Person for Pharmacovigilance (QPPV), and as appropriate to Senior Management and Health Authorities (HA). This position also provides strategic subject matter expertise to the development of scheduled and unscheduled safety assessments, safety reports and risk management documents.</p> <p>Key Responsibilities</p> <ul> <li>Provides strategic leadership for assessment of safety concerns, confirmation of safety signals, advice on risk mitigation actions and communication of safety-related concerns (including ESI/SSI) </li><li>Leads strategy of responding to queries from Regulatory Authorities, commercial partners and internal stakeholders on safety concerns and risk management </li><li>Ensures strategic insights are applied to oversight of queries from the safety and medical teams on safety-related content and study protocols </li><li>Oversees approval of safety-related content for press releases and other public and professional communications </li><li>Reviews results of available data from external and internal sources including spontaneous adverse event reports, safety data from non-spontaneous (solicited sources), results of signal detection and provides medical clinical expertise for causality assessments and conclusions of aggregate safety reviews. </li><li>Provides subject matter expertise to the development of scheduled and unscheduled safety assessments and reports </li></ul> <p>Applies a systematic approach to identification of the need for management of risks to maximize the safety profile of the product, as appropriate for product type, throughout a product's lifecycle including ensuring that:</p> <ul> <li>Required changes are made to the product labelling </li><li>Risk mitigation strategies are in place as appropriate </li><li>Safety strategic insights to guide where appropriate R&D activities are communicated </li><li>Appropriate risk management documentation is in place </li></ul> <p>What we are looking for</p> <p>Required Qualifications</p> <ul> <li>Experience in safety inspections and understanding of global safety regulations preferred. </li><li>Fully Licensed Physicans </li><li>Minimum of 4 years' experience in medical safety within Consumer sector or drug safety or development in Pharma and Medical Devices sector </li><li>Basic understanding of drug development, pharmacology, clinical trial methodology and design, and assessment of drug benefits vs. risks is a must. </li><li>Knowledge of biostatistics and epidemiology is preferred. </li><li>Ability to critically evaluate safety data from multiple sources (clinical trials, post-marketing, and literature, etc.). </li><li>Ability to influence, negotiate and communicate with both internal and external stakeholders. Excellent communication skills, both written and verbal. </li><li>Proficiency in Word, excel and PowerPoint is desired </li></ul> <p>What's in it for you</p> <p>Annual base salary for new hires in this position ranges from $238,000 - $322,000. This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.</p> <ul> <li>Competitive Total Rewards Package* </li><li>Paid Company Holidays, Paid Vacation, Volunteer Time & More! </li><li>Learning & Development Opportunities </li><li>Employee Resource Groups </li><li>This list could vary based on location/region </li><li>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. </li></ul>