Pharmacovigilance Safety Manager

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide If so we want to hear from you!

QPS is seeking an experienced Pharmacovigilance Safety Manager to lead our Safety Team and oversee the Safety Management process for clinical 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 to learn more about QPS Holdings LLC.

The Job

• 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

Work Location

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

Why You Should Apply

• 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.
• Solid benefits package including Company-matched 401(k) Company-sponsored Group Life/AD&D and Short- and Long-term Disability Insurance.
• Employee-focused internal committees designed around the needs interests and enjoyment of QPS employees.

Join QPS and play an important role in ensuring safety compliance and quality across our clinical trials while helping lead and develop our growing Safety Team.

For US candidates - QPS LLC is an Equal Employment Opportunity/Affirmative Action accordance with US/federal state and local laws 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 addition QPS LLC is a federal contractor and desires priority referrals of protected veterans.

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