Description

Kenvue is currently recruiting for: Associate Regional Medical Safety Officer (a RMSO)

This position is a manager position and reports into Regional Medical Safety Officer (RMSO) and is based at Sao Paulo, Brazil

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.

What you will do:

The Associate Regional Medical Safety Officer (a RMSO) is responsible for supporting the RMSO in the assessment of the benefit-risk of products authorized in the assigned region (LATAM). The a RMSO also provides guidance and medical safety inputs for their assigned portfolio into the development of products for their region.
The a RMSO proactively collaborate 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 a RMSO may be assigned ownership of processes or vendor oversight, as needed, and shall ensure that performed activities fulfil the relevant regulatory requirements and all applicable Kenvue processes.
The a 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.

Key Responsibilities:

• 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);
• Supporting, in collaboration with Global Risk Assessment and Safety Physicians (GRASPs), global post-market safety surveillance and risk management activities for active ingredients of consumer products;
• Supporting 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 representing Medical Safety at the Quality Review Boards (QRBs) when needed.
• Ad-hoc representation at cross-functional forums such as the Qualified Person Responsible for Pharmacovigilance (QPPV) meetings, Technical Review Forums, Medical Safety Council;
• Participation at the Complaint Vigilance Review Boards (CVRBs) and provision of medical safety inputs on observed trends and adverse events for products within the region when needed.
• 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 harm, assess acceptability and required mitigation
• Inputs into surveillance strategy for specific products marketed within the region
• Support the 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
• Ensure that safety decisions balance the interests of consumers/patients and other stakeholders to achieve industry-leading performance and quality of care.
• Works closely with other functions supporting safety-related activities such as MCSS (e.g., Medical Affairs, Toxicology, Clinical Safety), 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

We would love to hear from YOU, if you have:

• MD degree is required.
• Healthcare professional with at least 3 years clinical experience.

• Three or more years of industry experience/ pharmacovigilance/safety-related positions is preferred.

Experience and Skills:

• 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 it into simple, effective communications in both written and oral formats, to inform and align stakeholders to safety recommendations, is essential.

• Ability to work with diverse topics simultaneously and to demonstrate prioritization.

• 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.

• Fluency in English, Portuguese.
• Computer-literate and proficient in MS Office applications.

In return, we offer:

• Competitive Salary & Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Employee Resource Groups

• 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
Latin America-Brazil-São Paulo-São Paulo
Job Function Regional Medical Safety Officer

Primary Location Latin America-Brazil-São Paulo-São Paulo

Job Function Drug & Product Safety Science