Regional Medical Safety Officer EMEA

Regional Medical Safety Officer EMEA

Ce que nous faisons

Chez Kenvue, nous réalisons le pouvoir extraordinaire des soins quotidiens. S'appuyant sur plus d'un siècle d'héritage et enraciné dans la science, nous sommes la maison de marques emblématiques - dont NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® et BAND-AID® que vous connaissez et aimez déjà. La science est notre passion ; Le soin est notre talent.

Qui nous sommes

Notre équipe mondiale est composée de ~ 22 000 personnes brillantes avec une culture d'entreprise où chaque voix compte et chaque contribution est appréciée. Nous sommes passionnés par les idées, l'innovation et l'engagement à fournir les meilleurs produits à nos clients. Avec de l'expertise et de l'empathie, être un Kenvuer signifie avoir le pouvoir d'avoir un impact sur des millions de personnes chaque jour. Nous donnons la priorité aux personnes, nous nous soucions farouchement, nous gagnons la confiance grâce à la science et nous résolvons les problèmes avec courage - et nous vous offrons de brillantes opportunités ! Joignez-vous à nous pour façonner notre avenir et le vôtre. Pour plus d'informations, cliquez sur ici.

Role relève à :

Senior Director Medical Affairs EMEA

Lieu :

Europe/Middle East/Africa, Poland, Mazowieckie, Warsaw

Lieu de travail :

Hybride

Ce que tu vas faire

Position Summary:

The Regional Medical Safety Officer (RMSO) is accountable for assessing the benefit-risk of products authorized in the assigned region. The RMSO also provides guidance and medical safety inputs into the development of products for their region or globally, as required.  

The RMSO serves as the primary point of contact for post-approval medical safety-related matters as well as leading responses to safety-related questions from within the region, including local and regional regulatory authorities. The RMSO, throughout the product lifecycle, collaborates closely with  relevant cross-functional partners, as required, to ensure that all potential safety concerns for products authorized in their assigned regions are identified, assessed, and managed appropriately from the benefit-risk and risk management requirements. The RMSO drives informed decision-making from the medical safety perspective within the region. The RMSO serves as an integral member of due diligence teams and provides medical safety inputs on in-licensing and acquisition opportunities within the assigned portfolio.

The RMSO 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.

RMSO, EMEA may also serve as a global subject matter expert for safety related topics referable to Skin Health and Essential Health products at the request of other regional MSOs or cross-functional partners. 

The RMSO ensures that significant safety information is communicated in a timely and effective manner to the Chief Medical Officer, Heads of Regional Medical and Safety Sciences, Head of Product Vigilance, and other key internal and external stakeholders in accordance with established procedures.

Principle responsibilities:

Provision of medical insights on safety deliverables for the assigned portfolio of products marketed within the region. This includes:

• Provision of technical and strategic direction on Skin Health and Essential Health-related topics to other Regional MSOs and cross-functional teams
• 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)

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

Ensure that safety decisions balance the interests of consumers/patients and other stakeholders to achieve industry-leading performance and quality of care

Working relationships and Interfaces:

Works closely with other functions supporting safety-related activities such as MCSS (e.g., Medical Affairs, Toxicology, Clinical Safety), the RMSOs in other regions, GRASPs, Medical Safety Physicians, Signal Detection and Management group, Local Pharmacovigilance team, Pharmacovigilance Physicians, QPPV Office, Regulatory, the broader Research & Development (R&D) organization, Quality and Commercial teams; and represents the Medical Safety Position at various cross-functional forums (e.g., QRB, CVRB, SMT, QPPV meetings, Executive Quality Council, Technical Review Forums, Medical Safety Council, as necessary. Notifies/escalates significant safety issues to the Head of Regional MCSS, Head of Product Vigilance or the Chief Medical Officer and other stakeholders as appropriate.

Qualifications and Experience:

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

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