Global Risk Assessment Safety Physician

Kenvue•Jersey City, NJ

21h•Hybrid

About The Position

Kenvue is currently recruiting for a: Global Risk Assessment Safety Physician 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. For more information, click here. The Global Risk Assessment Safety Physician (GRASP) is a medical safety expert who provides medical oversight of the product safety risk assessment and characterization of the emerging and known product safety profiles for assigned Kenvue portfolio throughout the product lifecycle. The GRASP also ensures communication of potential and known risks, when appropriate, to direct management, regional medical management, Qualified Person for Pharmacovigilance (QPPV), and personnel in all other relevant functional areas. The GRASP is responsible for the development strategy of safety concerns assessment, ad hoc safety reports, safety signal management, PSURs/PBRERs, risk management, internal and external due diligence activities, provides recommendation for risk minimization if deemed and chairs Safety Management Team (SMT) meetings. Leads, under direction of the Head of Global Safety Risk Management, the strategy of responding to queries from Regulatory Authorities, commercial partners and internal stakeholders on safety concerns and risk management. The GRASP may be assigned ownership of processes or vendor oversight, as needed, and shall ensure that performed activities fulfill the relevant regulatory requirements and all applicable Kenvue processes.

Requirements

Physician (MD) with at least 3 years clinical experience.
Ability to analyze, interpret and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential.
Attention to detail
Diligence in record-keeping and records organization
Ability to manage high workload and critical issues
Computer-literate and proficient in MS Office applications
Team player who displays initiative, have strong communication and presentation skills
Strong collaborative and interpersonal skills
Results-oriented and able to independently create and deliver
Ability to thrive in a global, cross-functional environment.

Nice To Haves

Five or more years industry experience in medical safety is preferred.

Responsibilities

Review safety data available from external and internal sources including spontaneous adverse event reports, safety data from non-spontaneous (solicited sources), results of signal detection
Evaluation and communication of safety-related concerns (including ESI/SSI)
Chairing periodic Benefit-Risk Review by the SMT
Development of signal detection strategy and ad hoc reports
PSUR/PBRER strategy and reviews
Advice on risk mitigation actions including providing direction at Labeling Working Groups (LWGs) and other relevant portfolio forum/Committees
Providing support for due diligence activities
Development of safety plans for new products and indications
Leading strategy of responding to queries from Regulatory Authorities, commercial partners and internal stakeholders on safety concerns and risk management including development of appropriate documentation
Approval of safety-related content for press releases and other public and professional communications
Initiates escalation of safety signals/concerns to the Medical Safety Council (MSC) and senior management as appropriate
Ensures strategic safety insights are applied to oversight of queries from the safety and medical teams on safety-related content and study protocols
Process development and ownership, potentially including vendor oversight
Handle and assimilate large data sets and draw objective conclusions using appropriate analyses
Understand the clinical application/use of the technology/medication/product and assess the potential for a safety risk and need for risk minimization