Global Risk Assessment Safety Physician

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.

Role reports to:

QPPV HEAD OF SAFETY SCIENCE AND POLICY

Location:

North America, United States, New Jersey, Summit

Work Location:

Hybrid

What you will do

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.

Key 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

What we are looking for

Required Qualifications

• Physician (MD) with at least 3 years clinical experience.

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

• Ability to analyze, interpret and present complex data in a concise