Join to apply for the Regional Medical Safety Officer EMEA role at Kenvue.

About Kenvue

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.

Role Reports To

Senior Director Medical Affairs EMEA

Location

Europe/Middle East/Africa, Poland, Mazowieckie, Warsaw. Work Location: Hybrid.

What You Will Do

The Regional Medical Safety Officer (RMSO) is accountable for assessing the benefit‑risk of products authorized in the assigned region.

As the primary point of contact for post‑approval medical safety‑related matters and leading responses to safety‑related questions from within the region, the RMSO drives informed decision‑making from a medical safety perspective within the region.

In addition, the RMSO may be assigned ownership of processes or vendor oversight; serves as a global subject matter expert for safety topics referable to Skin Health and Essential Health products as requested; and ensures significant safety information is communicated in a timely and effective manner to key stakeholders.

Key Responsibilities

• Provision of medical insights on safety deliverables for the assigned portfolio of products marketed within the region.
• Provision of technical and strategic direction on Skin Health and Essential Health‑related topics to other Regional MSOs and cross‑functional teams.
• Provision of 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 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.

Decision Making and Problem Solving

• 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.

Working Relationships and Interfaces

Works closely with functions supporting safety‑related activities such as MCSS (Medical Affairs, Toxicology, Clinical Safety), RMSOs in other regions, GRASPs, Medical Safety Physicians, Signal Detection and Management group, Local Pharmacovigilance team, Pharmacovigilance Physicians, QPPV Office, Regulatory, R&D, Quality and Commercial teams; and represents the Medical Safety Position at various cross‑functional forums. Notifies/escalates significant safety issues to key stakeholders as appropriate.

Qualifications and Experience

• Physician (MD or equivalent degree) with at least 3 years clinical experience.
• Five or more years industry experience in medical safety and/or at least 2 years in pharmacovigilance/safety‑related positions.
• Expertise in primary care medicine, dermatology, clinical toxicology, public health, epidemiology, or related disciplines.
• 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.
• 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.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Additional Information

Senior level: Executive. Employment type: Full‑time. Job function: Research. Industries: Personal Care Product Manufacturing.

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