Regional Medical Safety Officer

Há 1 mês

São Paulo, São Paulo, Brasil Johnson & Johnson Consumer Inc Tempo inteiro
Job Summary

We are seeking a highly skilled Regional Medical Safety Officer to join our team in LATAM. As a key member of our Medical Safety team, you will be responsible for supporting the assessment of the benefit-risk of products authorized in the assigned region.

Key Responsibilities

* Provide medical insights on safety deliverables for the assigned portfolio of products marketed within the region.
* Support 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.

Requirements

* 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.

What 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.

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