Clinical Safety Director

2 weken geleden

Groningen, Groningen, Nederland QPS Voltijd

QPS Netherlands B.V. in Groningen is part of an international organization and conducts drug research on behalf of international pharmaceutical and biotechnological companies. As a leading organization in this field, we are seeking an experienced Clinical Safety Director to lead and oversee the Safety Management process within clinical trials.

About the role:

  • Oversee the entire Clinical Safety Management process for clinical trials, establishing and maintaining safety reporting procedures.
  • Act as the primary contact for sponsors, clinical project managers, and the QPS Safety Unit team, ensuring effective communication and collaboration.
  • Collaborate with the finance team to manage project setup, budgeting, and invoicing, ensuring compliance with company policies.
  • Develop and maintain Clinical Safety Management Plans, safety databases, and related documents, adhering to international safety reporting regulations and guidelines.
  • Lead clinical safety team meetings and ensure effective communication with all involved parties, fostering a collaborative and safe work environment.

Requirements:

  • Strong knowledge of international safety reporting regulations and guidelines (GCP, Eudravigilance).
  • Working knowledge of Safety Reporting requirements within clinical studies.
  • Proven experience in clinical trials or CROs, with a strong track record of leadership and management.
  • Excellent organizational and communication skills, with business level English skills.
  • Possesses strong analytical thinking, with the ability to thoroughly research, evaluate, and apply critical information effectively.
  • Exhibits strong attention to standards and impact, thinking things through and consistently demonstrating thoroughness and accuracy in their work.
  • University degree in a relevant discipline or equivalent experience.

What we offer:

This is an opportunity to take on a pivotal role in a leading organization where your leadership will shape our clinical safety efforts. If you're ready to bring your expertise to a dynamic team that values innovation and quality, we would love to hear from you.

Vaccination protocol:

As an employee of QPS, you are expected to participate in the vaccination program for health purposes. This includes a Hepatitis B vaccination. By applying for this job, you automatically accept to participate in this vaccination program when hired. For details, please ask the HR department.

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