Clinical Safety Manager

1 maand geleden

Groningen, Nederland QPS, LLC Voltijd

**Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you**

QPS is seeking an experienced **Clinical Safety Manager** to lead the safety team 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, the Netherlands, **Austria **or **the Czech Republic.**

**QPS’ Story**:
Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II - IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.

Team members enjoy challenging and rewarding work and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, teamwork and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals.

**The Job**
- 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 **will** be 100%** home-office based and may be filled in the US, Austria, Czech Republic or the Netherlands (ask to see Telecommuting Policy for full details).

**Requirements**:

- Strong knowledge of international safety reporting regulations and guidelines (GCP, Eudravigilance); this person will be our go-to for global safety guidance
- 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

**Why You Should Apply**
- Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.
- Structured Career Ladders that provide excellent growth based on your personal aspirations.
- Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.
- Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance
- Internal committees designed with the needs and enjoyment of QPS employees in mind.

**Join us** to make a meaningful impact on safety in clinical trials, ensuring compliance and delivering excellence in pharmacovigilance

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