Clinical Safety Leadership Role
vor 1 Tag
We are seeking a seasoned Clinical Safety Manager to lead our safety team and oversee the Safety Management process within clinical trials. With this role, you will have the opportunity to establish safety reporting procedures, manage pharmacovigilance services, and serve as the primary point of contact for sponsors, clinical teams, and subcontractors.
Responsibilities:- Oversight of the entire Clinical Safety Management process for clinical trials
- Serving as the main contact for sponsors, clinical project managers, and the QPS Safety Unit team
- Collaboration with the finance team to manage project setup, budgeting, and invoicing
- Ensuring compliance with safety reporting requirements, including Eudravigilance registration
- Development and maintenance of Clinical Safety Management Plans, safety databases, and related documents
- Leading clinical safety team meetings and ensuring 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 (business level English skills required)
- Strong analytical thinking – demonstrates 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 work
- University degree in relevant discipline or equivalent experience
- Estimated annual salary: $95,000 - $120,000 depending on location (US, Austria, Czech Republic, or Netherlands)
- Great learning opportunities, especially for those new to the field
- Structured Career Ladders providing excellent growth based on personal aspirations
- Bonuses and merit increases as part of total rewards approach 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
This is a fully remote role that offers a unique opportunity to make a meaningful impact on safety in clinical trials, ensuring compliance and delivering excellence in pharmacovigilance. As an Equal Employment Opportunity/Affirmative Action Employer, QPS values diversity and promotes a culture of innovation, accountability, teamwork, and a friendly atmosphere where performance is recognized and rewarded.
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