Senior Pharmacovigilance Lead
Vor 4 Tagen
At QPS, we are committed to improving human health and the quality of life. We are seeking an experienced Senior Pharmacovigilance Lead to join our team.
This is a unique opportunity to lead the safety team and oversee the Safety Management process within clinical trials. As a Senior Pharmacovigilance Lead, 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.
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
- 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)
- 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
- Competitive salary: $90,000 - $120,000 per year
- 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.
This role will be 100% home-office based and may be filled in the US, Austria, Czech Republic or the Netherlands.
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