SENIOR SCIENTIST, QPPV OFFICE

SENIOR SCIENTIST, QPPV OFFICE

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Qualified Person for Pharmacovigilance

Locatie:

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

Werklocatie:

Volledig op afstand

Wat je gaat doen

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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