Clinical Safety Manager
vor 3 Wochen
QPS is seeking an experienced Clinical Safety Manager to lead and oversee the Safety Management process within clinical trials.
This role involves establishing safety reporting procedures, managing pharmacovigilance services, and serving as the main point of contact for sponsors, clinical teams, and subcontractors.
The ideal candidate will have strong knowledge of international safety reporting regulations and guidelines (GCP, Eudravigilance), excellent organizational and communication skills, and the ability to think critically and thoroughly research information.
Responsibilities:
- 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
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
- 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
Why QPS:
- 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
- Park-like setting in Newark, Delaware
- Internal committees designed with the needs and enjoyment of QPS employees in mind.
QPS is an Equal Employment Opportunity/Affirmative Action Employer.
We recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law.
Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job.
In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.
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