Junior Global Risk Safety Physician
- Función del trabajo:
- Fecha de publicación:
- Fecha de finalización:
- ID:
- 2507038605W
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Lo que hacemos
En Kenvue, nos damos cuenta del extraordinario poder del cuidado diario. Sobre la base de más de un siglo de herencia y arraigados en la ciencia, somos el hogar de marcas icónicas, incluidas NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® y BAND-AID® que ya conoces y amas. La ciencia es nuestra pasión; El cuidado es nuestro talento.
Quiénes somos
Nuestro equipo global está formado por ~ 22.000 personas brillantes con una cultura laboral en la que cada voz importa y cada contribución es apreciada. Nos apasionan las ideas, innovación y comprometidos con la entrega de los mejores productos a nuestros clientes. Con experiencia y empatía, ser un Kenvuer significa tener el poder de impactar a millones de personas todos los días. Ponemos a las personas en primer lugar, nos preocupamos ferozmente, nos ganamos la confianza de la ciencia y resolvemos con coraje, ¡y tenemos oportunidades brillantes esperándote! Únase a nosotros para dar forma a nuestro futuro y al suyo. Para obtener más información, haga clic en aquí.
Role reports to:
QPPV HEAD OF SAFETY SCIENCE AND POLICYUbicación:
Asia Pacific, Philippines, National Capital, ParanaqueLugar de trabajo:
HíbridoWhat will you
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.
Si usted es una persona con una discapacidad, consulte nuestra página de Disability Assistance para obtener información sobre cómo solicitar una adaptación.