Head of QPPV Network and PV Governance

Purpose of the job position:

The Head of QPPV Network and PV Governance is responsible for leading, overseeing, and optimizing the provision of regional Qualified Persons for Pharmacovigilance (QPPVs) and local PV roles (e.g. PV Person at National Level, Person Responsible for Local Literature Screening, or similar), as well as the oversight activities associated with these functions.
This includes ensuring the effective operation of the PV system and its associated Quality Management System (QMS), maintaining the Pharmacovigilance System Master File (PSMF), monitoring the portfolio safety profile, supporting the implementation of risk minimization measures, managing communication with PV stakeholders and Health Authorities, and overseeing overall regulatory compliance. This leadership role ensures harmonized service delivery across the above functions, sustained inspection readiness, and the robust operation of iVigee's pharmacovigilance system. The role is performed remotely from anywhere in Europe.

MAJOR TASKS AND RESPONSIBILITIES:

Leadership of QPPV Office 

• Provide direct line management to the QPPV Network and PV Governance staff, fostering growth, regulatory compliance, and scientific rigor. 

Functional Strategy, Organisation and Commercial Acumen

• 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.

Quality and Compliance Oversight 

• 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. 

QPPV Network and PV Governance Operations

• 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, including:

o   Maintaining a compliant PV system, including PSMF management, KPI monitoring, and timely remediation of any identified non-compliance

o   Overseeing product safety profiles and emerging safety concerns, including support in risk minimization measures implementation

o   Tracking safety commitments and regulatory obligations to ensure ongoing awareness and fulfilment

o   Ensuring that all PV information submissions are prepared and filed in accordance with applicable regulations

o   Serving as the 24/7 PV contact point for Competent Authorities

o   Representing Clients during PV audits and inspections

Vendor Management

• 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.

Contribution to Business Development

• 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; service pricing remains with Business Development.
• Participate in client meetings and bid defenses as the subject matter expert for QPPV network and PV governance services.

Training and Regulatory Awareness 

• 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. 

Collaboration and Representation 

• 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. 

Specific requirements for the position: