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SENIOR SCIENTIST, QPPV OFFICE

职位职能:
发布日期:
结束日期:
ID:
2507036235W

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Kenvue 目前正在招聘 a:

SENIOR SCIENTIST, QPPV OFFICE

我们做什么

Kenvue,我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础,植根于科学,是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成,他们的职场文化中,每个声音都很重要,每一个贡献都受到赞赏。 我们热衷于洞察, 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心,成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本,热切关怀,以科学赢得信任,以勇气解决——有绝佳的机会等着您!加入我们,塑造我们和您的未来。有关更多信息,请单击 here.

Role reports to:

Qualified Person for Pharmacovigilance

位置:

Europe/Middle East/Africa, Poland, Mazowieckie, Warsaw

工作地点:

完全远程

你会做什么

KENVUE is seeking a Senior Scientist to support the Qualified Person for Pharmacovigilance (QPPV) in ensuring the effective and compliant operation of our pharmacovigilance (PV) system. The ideal candidate will have a strong background in pharmacovigilance and a proactive, solution-oriented approach to their work. This role involves collaborating with various teams, suggesting practical solutions, and maintaining detailed records to support inspection readiness and risk management.

The job is 100% remote, we can accept application from within the whole territory of Poland.

Key Responsibilities:

  • Collaboration and Support:
    • Collaborate with and support the EU QPPV and Deputy in providing guidance and oversight to the KENVUE pharmacovigilance system, including local QPPVs based in the EMEA region, to ensure inspection readiness.
  • Process Improvement:
    • Suggest and initiate the implementation of practical, risk-based solutions and processes that complement functional group practices, aiming to enhance efficiency and streamline operations.
  • Compliance and Safety Monitoring:
    • Escalate any arising compliance and safety issues to the QPPV and Deputy.
    • Monitor and track these issues until resolution, ensuring clear and transparent communication channels and detailed documentation.
  • Risk Management:
    • Support the review of Risk Management Plans, applying a risk-based approach to identify, prioritize, and manage risks.
    • Ensure that the plans are thorough, regularly updated, and aligned with regulatory requirements.
  • Regulatory Expertise:
    • Be an expert in EU pharmacovigilance regulations, including Good Pharmacovigilance Practices (GVP) and the General Data Protection Regulation (GDPR).
    • Monitor changes in the legal environment, support and track QPPV reviews and impact assessments, and provide feedback to appropriate functions for any necessary internal process changes.
  • Meeting Coordination:
    • Support EMEA inspections, QPPV meetings and projects as required
    • Assist in managing QPPV Mailboxes to ensure timely and effective communication.
  • Document Management:
    • Assist the QPPV Office with document management and archiving, ensuring all records are maintained accurately and efficiently.

Job Requirements

  • Minimum 5+ years of relevant experience in pharmacovigilance, drug safety, or a related scientific field with a strong track record of collaboration with medical safety, regulatory affairs, and commercial functions.
  • Strong knowledge of international pharmacovigilance regulations (e.g., EMA, FDA, ICH, GVP).
  • Operational, cooperative, and solution-oriented individual with a proactive approach to problem-solving.
  • Excellent written and verbal communication skills.
  • Ability to work collaboratively in a cross-functional team and manage multiple priorities.

Preferred Qualifications

  • Advanced degree (PharmD, MD, or MSc) in Life Sciences, Pharmacy, Medicine, or a related field.
  • Prior experience working within a QPPV Office or in support of a QPPV function.
  • Preferably with technological skills in Power BI to enhance data analysis and reporting capabilities.
  • Strong administrative skills, including the ability to manage documents, coordinate meetings, and maintain detailed records.

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         
  • This list could vary based on location/region 

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