Pharmacovigilance Safety Manager

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🔥 0 minutes ago

🌐 United States, Austria, +1 more countries – Remote

🇺🇸 United States – Remote 🇦🇹 Austria – Remote 🇳🇱 Netherlands – Remote

💵 $100k - $130k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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QPS

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1986

🤝 B2B

☁️ SaaS

🏢 Enterprise

B2B • SaaS • Enterprise

QPS is a software design company specialized in hydrographic and maritime applications. It develops system-integration and data-processing software used for hydrographic surveys, multibeam seafloor mapping, piloting and navigation, ENC production and 4D geospatial analysis. Products include Qinsy (survey & navigation), Qimera (multibeam processing), Fledermaus (4D analysis), Qarto (bathymetric ENC production) and Qastor (precise piloting). QPS operates from headquarters in Zeist (Netherlands) with offices in the UK, Canada and the USA and is regarded as a market leader in hydrographic survey software.

📋 Description

• 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

🎯 Requirements

• Strong knowledge of international clinical safety reporting regulations and guidelines, including GCP and EudraVigilance • 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 • 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

🏖️ Benefits

• Opportunities to learn and grow • Support from experienced professionals for continued development and career goals • Structured Career Ladders • Performance-based rewards, including bonuses and merit increases linked to individual, team, and company performance • Company-matched 401(k) • Company-sponsored Group Life/AD&D • Short- and Long-term Disability Insurance • Employee-focused internal committees designed around the needs, interests, and enjoyment of QPS employees • Friendly atmosphere where performance is recognized and rewarded • Training and opportunities for advancement