Global Risk Assessment Safety Physician

Global Risk Assessment Safety Physician

Что мы делаем

At Kenvue, мы осознаем необычайную силу повседневной заботы. Основанный на более чем вековом наследии и уходящий корнями в науку, мы являемся домом культовых брендов, включая NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® и BAND-AID®, которые вы уже знаете и любите. Наука – наша страсть; забота – это наш талант.

Кто мы

Наша глобальная команда – это ~ 22 000 блестящих людей с культурой рабочего места, где каждый голос имеет значение, а каждый вклад ценится. Мы увлечены идеями, инновации и стремление поставлять нашим клиентам лучшие продукты. Обладая опытом и эмпатией, быть Kenvuer означает иметь возможность влиять на миллионы людей каждый день. Мы ставим людей на первое место, заботимся о настолько, завоевываем доверие наукой и смело решаем – и вас ждут блестящие возможности! Присоединяйтесь к нам, чтобы формировать наше будущее и ваше. Для получения дополнительной информации, нажмите here.

Role reports to:

QPPV HEAD OF SAFETY SCIENCE AND POLICY

Местонахождение:

Asia Pacific, Philippines, National Capital, Paranaque

Место работы:

Гибрид

Что ты будешь делать

The Global Risk Assessment Safety Physician (GRASP) is a medical safety expert who provides medical oversight of the product safety risk assessment and characterization of the emerging and known product safety profiles for assigned Kenvue portfolio throughout the product lifecycle. The GRASP also ensures communication of potential and known risks, when appropriate, to direct management, regional medical management, Qualified Person for Pharmacovigilance (QPPV), and personnel in all other relevant functional areas. He/She is responsible for the development strategy of safety concerns assessment, ad hoc safety reports, safety signal management, PSURs/PBRERs, risk management, internal and external due diligence activities, provides recommendation for risk minimization if deemed and chairs Safety Management Team (SMT) meetings.  He/She leads, under direction of the Head of Global Safety Risk Management, the strategy of responding to queries from Regulatory Authorities, commercial partners and internal stakeholders on safety concerns and risk management, and 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.

Key Responsibilities

- Medical insights on safety deliverables for their assigned portfolio, including but not limited to:

• Review safety data available from external and internal sources including spontaneous adverse event reports, safety data from non-spontaneous (solicited sources), results of signal detection
• Evaluation and communication of safety-related concerns (including ESI/SSI)
• Chairing periodic Benefit-Risk Review by the SMT
• Development of signal detection strategy
• Development of ad hoc reports
• PSUR/PBRER strategy and reviews
• Advice on risk mitigation actions including providing direction at Labeling Working Groups (LWGs) and other relevant portfolio forum/Committees
• Providing support for due diligence activities
• Development of safety plans for new products and indications
• Leading strategy of responding to queries from Regulatory Authorities, commercial partners and internal stakeholders on safety concerns and risk management including development of appropriate documentation
• Approval of safety-related content for press releases and other public and professional communications
• Initiates escalation of safety signals/concerns to the Medical Safety Council (MSC) and senior management as appropriate

- Ensures strategic safety insights are applied to oversight of queries from the safety and medical teams on safety-related content and study protocols.

- Process development and ownership, potentially including vendor oversight

What we are looking for

Required Qualifications

• Physician (MD) with at least 3 years clinical experience.
• Five or more years industry experience in medical safety is preferred.
• Ability to analyze, interpret and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential.
• Critical thinking and agility in the evaluation of safety topics and development of processes
• Attention to detail, and diligence in record-keeping and records organization
• Ability to manage high workload and critical issues
• Computer-literate and proficient in MS Office applications
• Team player who displays initiative, have strong communication and presentation skills
• Strong collaborative and interpersonal skills
• Results-oriented and able to independently create and deliver
• Ability to thrive in a global, cross-functional environment.

What’s in it for you

• A dynamic opportunity to work in one of Kenvue’s fastest growing and most high profile businesses, with visibility to both global and regional stakeholders.
• Competitive Benefit Package
• Flexible Work Arrangement, Volunteering Days, Health and Wellness Reimbursements and much more!
• Learning & Development Opportunities
• Employee Resource Groups 

Kenvue is proud to be an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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