Regional Medical Safety Officer

Job Description

Kenvue is currently recruiting for-

Regional Medical Safety Officer, North America

This position reports to Head of Regional Medical and Safety Science, North America and is based at Summit, NJ, USA.

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- Head of Regional Medical and Safety Science

Location- Summit, NJ, USA

Travel %- 10

Pay- $238,000 - $322,000

What You Will Do

The Regional Medical Safety Officer, [North America] is responsible for Provision of medical insights on safety deliverables for the assigned portfolio of products marketed within the region. This includes-

• Provision of the medical safety inputs to new product development and throughout lifecycle management (PRM review)
• Leading strategy for post-market safety surveillance and risk management activities for products marketed within the region, including ad hoc Safety Management Team (SMT) meetings when needed
• Supporting, in collaboration with Global Risk Assessment and Safety Physicians (GRASPs), global post-market safety surveillance and risk management activities for active ingredients of the medicinal products
• Leading the medical safety evaluations of quality issues with potential impact on safety, in collaboration with other functions within Medical, Clinical and Safety Science (MCSS), Quality and SMT (when needed), and represent at the Quality Review Boards (QRBs)
• Regular or ad-hoc representation at cross-functional forums such as the Qualified Person Responsible for Pharmacovigilance (QPPV) meetings, Technical Review Forums, Medical Safety Council
• Representation at the Complaint Vigilance Review Boards (CVRBs) and provision of medical safety inputs on observed trends and adverse events for products within the region
• Provision of input on licensing and acquisition candidates, as necessary
• Leading safety-related activities and coordinating the response to queries from Regulatory Authorities, commercial partners and internal and external stakeholders on safety concerns and risk management, including development of appropriate documentation in support of new licensing applications/switches.
• Process development and ownership, talent development (including oversight of internal and vendor colleagues)
• Medical safety inputs into product development - leverage medical knowledge and post-marketing experience to understand the clinical/medical application of a product/technology and assess the potential for a hazard to result in a harm, assess acceptability and required mitigation
• Medical safety assessment to support business evaluation of Licensing and Acquisition opportunities
• Inputs into surveillance strategy for specific products marketed within the region
• Strategy for evaluation of safety topics, identified internally or externally, including identification of relevant stakeholders to engage, required information, format of response, communication and action plans, including, but not limited to consultation with/escalation to appropriate senior personnel and governance bodies
• Medical safety evaluations of significant quality issues with potential safety concern, including Medical Safety representation at the Quality Review Boards and assessment/identification of any additional required actions/mitigation
• Ensure that safety decisions balance the interests of consumers/patients and other stakeholders to achieve industry-leading performance and quality of care
  
  

Required Qualifications

• [Physician (MD or equivalent degree) with at least 3 years clinical experience is required.
  
  

Desired Qualifications

• Five or more years industry experience in medical safety and/or at least 2 years in pharmacovigilance/safety-related positions is preferred.
• Expertise in primary care medicine, dermatology, clinical toxicology, public health, epidemiology, or related disciplines is desirable
• Good understanding of safety and regulatory requirements for the different regulatory classes of products in the portfolio within the region
• Ability to critically evaluate safety data from multiple sources and translate into simple, effective communications in both written and oral formats, to inform and align stakeholders to safety recommendations, is essential.
• Strategic mindset that will allow agility and efficiencies to support the evolving science and industry, without compromising quality and compliance
• Ability to work with diverse topics simultaneously and to demonstrate prioritization, manage critical safety-related issues arising in the region in an efficient, effective, and timely manner
• Strong collaboration, communication, and interpersonal skills, with the ability to influence, negotiate, and communicate effectively at all levels, with both internal and external stakeholders
• Ability to thrive in regional and global, cross-functional environments.
  
  

What’s In It For You

• 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.
• Competitive Total Rewards Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Employee Resource Groups
• This list could vary based on location/region
• 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.
  
  

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

Primary Location

NA-US-New Jersey-Summit

Job Function

Drug & Product Safety Science

Job Qualifications

What we are looking for