Clinical Safety Manager

2 maanden geleden

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. We are seeking an experienced **Clinical Safety Manager** to lead and oversee the Safety Management process within clinical trials. In this role, you will be responsible for establishing safety reporting procedures, managing pharmacovigilance services, and serving as the main point of contact for sponsors, clinical teams, and subcontractors.

**This remote role may be filled in the US, in Austria or in the **Netherlands**.

**What will you do?**
- Oversee the entire Clinical Safety Management process for clinical trials
- Act as the primary contact for sponsors, clinical project managers, and the QPS Safety Unit team
- Collaborate with the finance team to manage project setup, budgeting, and invoicing
- Ensure compliance with safety reporting requirements, including Eudravigilance registration
- Develop and maintain Clinical Safety Management Plans, safety databases, and related documents Lead clinical safety team meetings and ensure effective communication with all involved parties

**Work Location**
- This job **may be 100%** home-office based (please ask to see Telecommuting Policy for full details).

**Who are you?**
- 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
- Excellent organizational and communication skills (must have business level English skills)
- Exhibits strong attention to standards and impact - thinks things through and consistently demonstrates thoroughness and accuracy in their work
- University degree in a relevant discipline or equivalent experience

**What do 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

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