Junior Global Risk Safety Physician

Junior Global Risk 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 Junior Global Risk Assessment Safety Physician (JGRASP) provides medical assessment of the product information pertinent to safety risk assessment and characterization of the emerging and known product safety profiles for assigned Kenvue portfolio products. The JGRASP 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. The JGRASP is responsible for providing medical assessment of individual and aggregate safety data, support safety concerns and safety signals assessment, development of ad hoc safety reports and PSURs/PBRERs.  He/She may be assigned development and/or ownership of processes, as needed, and shall ensure that performed activities fulfill the relevant regulatory requirements and all applicable Kenvue processes.

Key Responsibilities

Safety data assessment and medical insights on safety deliverables for assigned products, 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)
• Contribution to the development of signal detection strategy
• Contribution to the development of ad hoc reports
• PSUR/PBRER reviews
• Advice on risk mitigation actions
• Contribution to safety plans for new products and indications
• Incorporates new safety data into clinical practices and initiates core data sheet and label changes.
• Gathering safety data for responding to queries from Regulatory Authorities, commercial partners and internal stakeholders on safety concerns and risk management including development of appropriate documentation
• Guides analysis of database and literature searches, making conclusions about the safety signal or efficacy (or lack thereof).
• Documents results of the data review and the conclusions, actions, and advice given.
• Leads special projects related to drug and product safety.

What We Are Looking For

Key Qualifications

• A Licensed Physician
• Relative experience is preferred but not required
• Demonstrated ability to critically evaluate and analyze safety data from multiple sources (post-market reports, literature, etc.), and communicate findings to inform stakeholders
• Demonstrated ability to understand the clinical application/use of the technology/medication/product and assess the potential for a safety risk and need for risk minimization
• Demonstrated ability to carry out structured problem-solving and decision-making skills
• Demonstrated ability to communicate effectively complex topics with cross functional stakeholders
• Highly passionate in making a positive impact consumers’ lives

What’s In It For You

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• Learning & Development Opportunities
• Employee Resource Groups 
• Flexible Work Arrangements

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.

Если вы являетесь человеком с ограниченными возможностями, пожалуйста, ознакомьтесь с нашим страница помощи инвалидам для получения информации о том, как запросить приспособление.