Head of Global Risk Assessment
KenvueAbout the role
Description
Kenvue is currently recruiting for:
Head of Global Risk Assessment
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.
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® 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.
Role reports to: QPPV Head of Safety Science and Policy
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.
Travel %: 5%
Pay: $238,000 - $322,000
What you will do
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.
Key Responsibilities
- 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)
- Leads strategy of responding to queries from Regulatory Authorities, commercial partners and internal stakeholders on safety concerns and risk management
- Ensures strategic insights are applied to oversight of queries from the safety and medical teams on safety-related content and study protocols
- Oversees approval of safety-related content for press releases and other public and professional communications
- 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.
- Provides subject matt
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