Easter Seals Jobs

Description

Kenvue is currently recruiting for:

Global Risk Assessment & Safety Physician

This position reports to the Head of the Global Safety Risk Assessment Team and is based in Skillman, New Jersey.

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 that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact 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: Head of Global Safety Risk Assessment

Location: Kenvue's corporate headquarters is currently located in Skillman NJ, but is scheduled to move to Summit, NJ in or around early 2025.

Travel %: up to 10

Pay: Annual base salary for new hires in this position ranges from $132,000 to $226,500 . This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.

What you will do

The Global Risk Assessment & Safety Physician (GRASP) is a medical safety expert who provides medical oversight of safety risk assessment and characterization of emerging and known safety profiles throughout the product lifecycle for a portfolio of Kenvue products. The GRASP also ensures communication of potential and known risks, when appropriate, to direct management, regional medical management, the Qualified Person for Pharmacovigilance (QPPV), and personnel in all other relevant functional areas. The GRASP is responsible for developing the strategy for the assessment of safety concerns, ad hoc safety reports, safety signal management, oversight of PSURs/PBRERs, risk management, internal and external due diligence activities, risk minimization as needed and chairs Safety Management Team (SMT) meetings. The GRASP also leads, under direction of the Head of Global Safety Risk Assessment, the strategy for responding to queries from Regulatory Authorities, commercial partners and internal stakeholders regarding safety concerns and risk management.

Key Responsibilities
Review of safety data available from external and internal sources including spontaneous adverse event reports, safety data from non-spontaneous (solicited) sources, and results of signal detection
Evaluation and communication of safety-related concerns
Chair periodic benefit-risk review by the SMT
Development of signal detection strategy
Development of ad hoc safety reports
Periodic Safety Update Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER) strategy and reviews
Advise on risk mitigation actions including providing direction for Labeling Working Groups (LWGs) and other relevant portfolio fora/committees
Provide support for due diligence activities
Development of safety plans for new products and indications
Lead strategy for responding to queries from Regulatory Authorities, commercial partners and internal stakeholders on safety concerns and risk management including development of appropriate documentation
Approve safety-related content for press releases and other public and professional communications
Initiate escalation of safety signals/concerns to the Medical Safety Council (MSC) and senior management as appropriate

What we are looking for

Required Qualifications
Physician (MD or equivalent) required; with 2 or more years of pharmacovigilance experience or other relevant experience (e.g. clinical research, medical affairs) preferred
Demonstrated skills in clinical medicine with at least 3 years of clinical practice experience
Board Certification (if US) preferred; Medical specialization preferred
Late phase and post marketing experience preferred
Knowledge of principles of drug development, pharmacology, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs on the market and global safety regulations highly preferred
Ability to communicate, influence, and negotiate with both internal and external stakeholders

Desired Qualifications
Ability to review and assess large data sets and draw objective conclusions using appropriate analyses
Ability to understand the clinical application/use of assigned technology/medication/products and assess the potential for safety risks and the need for risk minimization
Strategic thinking and agility in the evaluation of safety topics and development of processes
Ability to carry out structured problem-solving and decision-making
Ability to critically evaluate and analyze safety data from multiple sources (postmarket reports, literature, etc.), and communicate findings
Ability to work with diverse topics simultaneously
Ability to communicate effectively complex topics with cross functional stakeholders
Ability to collaborate with multiple functions and lines of business
Ability to handle multiple products/product families simultaneously
Ability to manage complex products
Ability to meet timelines for deliverables according to Standard Operating Procedures


What's in it for you
Annual base salary for new hires in this position ranges from $132,000 to $226,550 . This takes into account a number of factors including work location, the candidate's skills, experience,...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity