Clinical Safety Manager

3 weken geleden

Groningen, Groningen, Nederland QPS Voltijd

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

About the Role

  • Oversee the entire Clinical Safety Management process for clinical trials, ensuring compliance with international safety reporting regulations and guidelines.
  • Act as the primary contact for sponsors, clinical project managers, and the QPS Safety Unit team, providing expert guidance and support.
  • Collaborate with the finance team to manage project setup, budgeting, and invoicing, ensuring seamless project execution.
  • Develop and maintain Clinical Safety Management Plans, safety databases, and related documents, ensuring accuracy and compliance.
  • Lead clinical safety team meetings and ensure effective communication with all involved parties, fostering a culture of collaboration and excellence.

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 success.
  • Excellent organizational and communication skills, with business-level English proficiency.
  • 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 program includes a Hepatitis B vaccination. By applying for this job, you automatically accept to participate in this vaccination program when hired. For details, you can ask the HR department.

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