Pharmacovigilance Safety Manager

QPS • Newark, DE

7d • 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. QPS' Story Since its inception, QPS has been assisting pharmaceutical, biotechnology, and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical, and Phase II – IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring, and committed individuals who work collaboratively toward our mission of improving human health and quality of life. Our team members enjoy challenging and rewarding work in a culture that values diversity, innovation, accountability, teamwork, and a friendly atmosphere where performance is recognized and rewarded. We offer unique company benefits, training, and opportunities for advancement. Most importantly, we value our team members both as employees and as individuals. If this sounds like your ideal work environment, we would love to speak with you. Apply today and visit www.qps.com to learn more about QPS Holdings, LLC.

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
• Work alongside experienced professionals who will support your continued development and career goals
• Structured Career Ladders that provide opportunities for growth based on your skills and aspirations
• Performance-based rewards, including bonuses and merit increases linked to individual, team, and company performance
• Employee-focused internal committees designed around the needs, interests, and enjoyment of QPS employees

What This Job Offers

• Job Type: Full-time
• Career Level: Manager