Deputy EU Pharmacovigilance Officer

3 weken geleden

Utrecht, Utrecht, Nederland Lilly Voltijd

Position Overview: We are in search of dedicated professionals who are passionate about enhancing global health outcomes.

Role Summary: The position of Deputy European Union (EU) Qualified Person for Pharmacovigilance (m/f/d) is critical in ensuring compliance with regulatory standards.

Key Responsibilities:

  • Act as a substitute for the EU QPPV to meet legal obligations during their absence.
  • Provide strategic and technical guidance on pharmacovigilance to Global Patient Safety (GPS) and other pertinent departments.
  • Engage actively in committees such as the Safety Review Committee (SRC).
  • Deliver training and leadership within the Global Patient Safety domain.
  • Represent the EU QPPV in the Global Product Labelling Committee (GPLC) when required.

Core Duties: This role may evolve and include additional responsibilities as necessary. Please consult with your supervisor for detailed job expectations.

Act as the EU Qualified Person for Pharmacovigilance:

  • Ensure adherence to legal and regulatory standards for the EU Qualified Person in the absence of the EU QPPV.
  • Stay updated on EU regulatory developments and provide timely insights to GPS leadership.
  • Offer expert advice on regulatory submissions and safety issues to maintain compliance.
  • Contribute to various committees and provide strategic recommendations.
  • Provide independent expertise on safety matters and support regulatory submissions.
  • Participate in pharmacovigilance forums to enhance knowledge and deliver training to relevant teams.
  • Engage in recruitment initiatives and offer insights on potential candidates.

Qualifications:

  • Medical degree with clinical experience.
  • Global exposure within the EU/EEA.
  • At least 5 years of experience in pharmacovigilance with a solid understanding of epidemiology principles.
  • Strong decision-making capabilities and the ability to influence diverse audiences.
  • Excellent interpersonal, communication, and teamwork skills.
  • Ability to thrive in multicultural settings and work independently.
  • Familiarity with the product safety regulatory landscape and drug development processes.
  • Solid understanding of quality systems and benefit-risk assessment methodologies.
  • A robust network and a commitment to continuous learning.
  • Willingness to travel and work flexible hours.

What We Offer:

Work Environment: We promote a culture of equality and collaboration.

Creative Opportunities: Share your ideas and shape your responsibilities from the outset.

Career Development: Access to personalized career growth and professional training through our 'Corporate Lilly University'.

Compensation and Benefits: Competitive salary, excellent pension plan, and additional individual benefits.

We look forward to your application.

Lilly is an equal opportunity employer.

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