Kenvueは現在、以下求人を募集しております。
SENIOR SCIENTIST, QPPV OFFICE私たちがしていること
私たちKenvueは、日々のケアが持つ驚くべき力を信じています。100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID®など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。
Who We Are
私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えたKenvuerであることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。
Role reports to:
Qualified Person for Pharmacovigilance場所:
Europe/Middle East/Africa, Poland, Mazowieckie, Warsaw勤務地:
完全リモートあなたがすること
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
障害のある個人の方は、宿泊施設のリクエスト方法について障害支援ページを確認してください。
