Assistant EU Qualified Person for Pharmacovigilance

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: As a:

Deputy European Union (EU) Qualified Person for Pharmacovigilance (m/f/d)

Key Responsibilities:

  • Act as a substitute for the EU QPPV when required to meet legal responsibilities during their absence.
  • Provide strategic and technical guidance on pharmacovigilance to Global Patient Safety (GPS) and associated departments.
  • Engage actively in various committees, including the Safety Review Committee (SRC).
  • Deliver training and leadership within the Global Patient Safety framework.
  • Represent the EU QPPV in the Global Product Labelling Committee (GPLC) as needed.

Core Duties: This position may evolve and include additional tasks not detailed here. Please consult your supervisor for precise job expectations.

Act as the EU Qualified Person for Pharmacovigilance:

  • Ensure compliance with legal and regulatory standards for the EU Qualified Person in the absence of the EU QPPV.
  • Stay updated on changes in EU regulations 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 insights.
  • Provide independent expertise on safety issues and support regulatory submissions.
  • Participate in pharmacovigilance forums to enhance knowledge and offer training to relevant teams.
  • Engage in recruitment initiatives and provide guidance on potential candidates.

Qualifications:

  • Medical degree with clinical experience.
  • Global experience within the EU/EEA.
  • At least 5 years of experience in pharmacovigilance with a solid understanding of epidemiology principles.
  • Strong decision-making abilities and capacity 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.
  • Good understanding of quality systems and benefit-risk assessment methodologies.
  • Strong professional network and commitment to continuous learning.
  • Willingness to travel and adapt to non-traditional working hours.

What We Offer:

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

Creative Opportunities: Contribute your insights and shape your responsibilities from the outset.

Career Development: Access individual career advancement and professional training through our 'Corporate Lilly University'.

Compensation and Benefits: Enjoy a competitive salary, comprehensive pension plan, and additional individual benefits.

We look forward to receiving your application.

Lilly is an equal opportunity employer.

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