Head of QPPV Network – PV Governance

🕒 October 30

🇨🇿 Czechia – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 24%

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iVigee

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2021

💊 Pharmaceuticals

🏥 Healthcare

🤖 Artificial Intelligence

Pharmaceuticals • Healthcare • Artificial Intelligence

iVigee is a physician-led pharmacovigilance company that provides end-to-end drug safety solutions for pharmaceutical and biotech organizations. iVigee offers managed pharmacovigilance services, expert consultancy, and pharmacovigilance technology (including AI-enabled tooling) to automate PV workflows, ensure regulatory compliance, and support inspection-ready processes. The leadership team includes former regulators and senior physicians, and the firm highlights AI strategy, validated agentic AI deployment, and global/local regulatory expertise with offices in Prague and Burlington, MA.

📋 Description

• Lead and oversee the provision of regional Qualified Persons for Pharmacovigilance (QPPVs) and local PV roles • Provide direct line management to QPPV Network and PV Governance staff • Set the function strategy and contribute to company-level decisions and resource planning • Negotiate pricing with Local PV expert vendors and contribute PV expertise to business proposals and contracts • Build the function’s organizational structure and succession and develop managers and senior staff • Own and optimize the PV Quality Management System, including SOPs, work instructions, templates, controlled documents, audits, inspections, and CAPA management • Ensure regulatory responsibilities for regional QPPV and local PV roles are fulfilled • Maintain the PV system, including PSMF management, KPI monitoring, and remediation of non-compliance • Oversee product safety profiles, emerging safety concerns, and risk minimization measures • Track safety commitments and regulatory obligations • Ensure PV information submissions are prepared and filed according to regulations • Serve as the 24/7 PV contact point for Competent Authorities • Represent clients during PV audits and inspections • Manage Local PV expert vendors and oversee vendor performance and compliance • Support business proposals and bids with scoping, effort estimates, and vendor cost estimates • Participate in client meetings and bid defenses as the subject matter expert • Lead internal training and monitor changes in PV regulatory requirements • Collaborate with other PV units and departments • Represent iVigee at conferences, forums, and external initiatives

🎯 Requirements

• M.D., Pharmacy, Life Sciences, or equivalent advanced degree • Minimum 5 years in pharmacovigilance • At least 3 years in a similar senior compliance function • In-depth knowledge of EU and global/local pharmacovigilance legislation, including GVP Modules I–XV • Proven ability to lead teams and complex quality/compliance systems • Active, hands-on use of AI tools in daily work, with concrete examples and ability to explain how outputs are verified • Excellent written and spoken English • Confident communicator with regulatory authorities • Advanced knowledge of Microsoft Office applications

🏖️ Benefits

• Work-life balance • Training and mentoring opportunities • Continuous learning and professional development • Reference calls with selected former supervisors at the final recruitment stage

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