Pharmacovigilance Safety Manager
QPS, LLC•Newark, DE
•$100,000 - $130,000•Remote
About The Position
QPS is seeking an experienced Pharmacovigilance Safety Manager to lead our Safety Team and oversee the Safety Management process for clinical trials. In this role, you will manage PV services, establish and maintain safety reporting processes, provide global safety guidance, and serve as the primary safety contact for sponsors, clinical teams, and subcontractors. You will also provide day-to-day leadership and support to a small Safety Team. This role may be filled in the US, Austria, Czech Republic or the Netherlands.
Requirements
- Strong knowledge of international clinical safety reporting regulations and guidelines, including GCP and EudraVigilance, with the ability to serve as a go-to resource for global safety guidance
- Working knowledge of safety reporting requirements within clinical studies
- Proven experience in clinical trials, a CRO environment, or a related field
- Experience leading, supervising, or providing day-to-day direction to PV/safety team members
- Excellent organizational and communication skills, including business-level English
- Strong analytical thinking, with the ability to research, evaluate, and apply complex information effectively
- Strong attention to standards, quality, and impact, with demonstrated thoroughness and accuracy
- University degree in a relevant discipline or equivalent combination of education and experience
Responsibilities
- Oversee the PV Safety Management process for clinical trials, ensuring high-quality and compliant delivery of safety activities
- Lead and support the Safety Team, providing day-to-day direction, guidance, and oversight of assigned work
- Serve as the primary safety contact for sponsors, clinical project managers, the QPS Safety Team, and other involved parties
- Provide guidance on global safety reporting requirements and ensure compliance with applicable regulations and guidelines, including GCP and EudraVigilance requirements
- Develop and maintain Clinical Safety Management Plans, safety databases, procedures, and related documentation
- Lead clinical safety meetings and facilitate effective communication among sponsors, project teams, subcontractors, and other stakeholders
- Collaborate with Finance and project teams on project setup, budgeting, and invoicing for PV services
Benefits
- Company-matched 401(k)
- Company-sponsored Group Life/AD&D
- Short- and Long-term Disability Insurance
- Opportunities to learn and grow
- Structured Career Ladders
- Performance-based rewards, including bonuses and merit increases
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What This Job Offers
Job Type
Full-time
Career Level
Manager
