Clinical Safety Management Lead
Vor 6 Tagen
We are seeking an experienced Clinical Safety Manager to lead and oversee the Safety Management process within clinical trials.
About QPSQPS is a leading provider of drug development services, offering a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services.
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
- 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)
- Possesses strong analytical thinking – demonstrates the ability to thoroughly research, evaluate, and apply critical information effectively
- 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
Estimated salary: $120,000 - $180,000 per year
Our comprehensive benefits package includes:
- Company-matched 401(k)
- Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance
- Bonuses and merit increases linked to individual, team, and company performance
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