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在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。
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我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.
Role reports to：
Qualified Person for Pharmacovigilance位置：
Europe/Middle East/Africa, Poland, Mazowieckie, Warsaw工作地點：
完全遠端你會做什麼
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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