IA
Head of QPPV Network and PV Governance
Contract type
Ongoing
Work mode
Remote · Europe
Experience
Senior · 5+ years
Job description
The Head of QPPV Network and PV Governance leads and oversees the provision of regional Qualified Persons for Pharmacovigilance (QPPVs) and local PV roles, plus the associated oversight activities, ensuring effective operation of the PV system and its QMS. The role is performed remotely from anywhere in Europe.
At a glance
- Work mode
- Remote · Europe
- Languages
- English – excellent
What you'll do
- Provide direct line management to the QPPV Network and PV Governance staff, fostering growth, regulatory compliance, and scientific rigor
- Own and set the strategy for the QPPV Network and PV Governance function, aligned with company objectives, and contribute the function's perspective to company-level decisions
- Carry accountability for the function's outcomes and cross-company alignment, including resource planning for the function's growth
- Apply commercial acumen in vendor relationships — negotiate pricing with Local PV expert vendors — and contribute PV expertise to iVigee business proposals and the resulting contracts
- Build the function's organisational structure and succession, and develop the managers and senior staff within it
- Own and continually optimize the PV Quality Management System, including SOPs, Work Instructions, templates, and controlled documents; audit and inspection readiness activities; internal audit planning and execution; CAPA management and documentation
- Promote compliance awareness and a quality-first mindset across all PV teams
- Ensure that all regulatory responsibilities associated with the provision of regional (i.e. EU, EAEU) QPPV or local PV roles — whether fulfilled by iVigee staff or by third parties — are met in accordance with applicable regulatory requirements and industry standards
- Maintain a compliant PV system, including PSMF management, KPI monitoring, and timely remediation of any identified non-compliance
- Oversee product safety profiles and emerging safety concerns, including support in risk minimization measures implementation
- Track safety commitments and regulatory obligations to ensure ongoing awareness and fulfilment
- Ensure that all PV information submissions are prepared and filed in accordance with applicable regulations
- Serve as the 24/7 PV contact point for Competent Authorities
- Represent Clients during PV audits and inspections
- Manage the network of Local PV expert vendors — sourcing, searching, qualifying and contracting vendors to meet client and regulatory needs
- Provide ongoing oversight of vendor performance and compliance with applicable regulatory requirements and contractual obligations
- Support iVigee business proposals and bids with QPPV network and PV governance expertise, including scoping and effort estimation for the offered services
- Provide time and effort estimates for QPPV and local PV role services offered in proposals, and vendor cost estimates for the covered territories
- Participate in client meetings and bid defenses as the subject matter expert for QPPV network and PV governance services
- Lead internal training strategy and delivery across PV compliance topics
- Monitor changes in PV regulatory requirements and cascade updates to relevant stakeholders
- Promote continuous learning and mentoring to the staff under the line management and to audit contributors
- Collaborate with heads of other PV units and other departments to ensure seamless integration and service delivery
- Act as the subject matter expert in regulatory authority interactions and client audits
- Represent iVigee at conferences, forums, and external initiatives related to QPPV or local PV practice and PV compliance
What we're looking for
- M.D., Pharmacy, Life Sciences, or equivalent advanced degree
- Minimum 5 years in pharmacovigilance, with at least 3 years in 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 — able to demonstrate concrete examples, including how outputs are verified
- Excellent written and spoken English; confident communicator with regulatory authorities
- Advanced knowledge of Microsoft Office applications
Your team
QPPV Network and PV Governance
Function responsible for the provision of regional QPPVs and local PV roles and associated oversight activities
How to get hired
- 1Thorough recruitment process applying the Topgrading methodology, covering career history, achievements, challenges, important decisions and key professional relationships
- 2At the final stage, shortlisted candidates will be asked to arrange reference calls with selected former supervisors
Apply
About iVigee Services, a.s.
Physician-lead pharmacovigilance exclusive company
iVigee combines deep regulatory expertise with AI-enabled tools (such as iViReg, iViTracker, iViSight) to support clients' drug safety life cycles. With strategic centres of excellence in Europe and the US, and a network of experts in over 150 countries, it services the complex global needs of its clients.
Key facts
- 2021
- Pharmacovigilance
- Founded in 2021
- All leaders have years of experience in all areas of pharmacovigilance - science, regulations, and technology
- World leading Pharmacovigilance Intelligence platform iViReg
- Strategic centres of excellence in Europe and the US
- Network of experts in over 150 countries
- Applies the Topgrading methodology
What they value
- Fearless
- Trustworthy professionals
- Enabling innovation
- Sustainable manner