AbbVie European Qualified Person Responsible For Pharmacovigilance in Rome, Italy
European Qualified Person Responsible For Pharmacovigilance
Italy, Lazio, Rome
The purpose of this role is to work in cooperation with various stakeholders to develop, implement, maintain and monitor an optimized Quality Management System for the Pharmacovigilance and Patient Safety (PPS) organization that at a minimum meets global regulatory legal requirements and standards. The scope extends to pharmacovigilance activities worldwide and spans the life cycle of all products.
Key Responsibilities Include :
Development, oversight and management of the PPS Quality System to enable PPS leadership, including the QPPV, in their oversight and maintenance of a robust PV system
Education and promotion of quality principles to inspire a quality mindset across PPS and Affiliate PV; management and development of a team of quality professionals to drive and ensure quality and compliance across all safety-related activities
Direct accountability for monitoring, communicating, and the continuous improvement of pharmacovigilance compliance through the management and oversight of PV system compliance and performance metrics, measures and management reports, including appropriate escalation of quality issues to senior management
Accountable to ensure timely and complete strategic assessments of global PV regulatory requirements and coordination of planning and implementation of global PV regulatory requirements
Development and maintenance of issue management systems, including the PV CAPA process, to ensure alignment with AbbVie policies; oversight and management of PV issues and exceptions with accountability to ensure appropriate and timely mitigation and resolution of risks.
Lead the preparation for PPS internal audit and PV inspections worldwide in collaboration with RDQA, accountable for appropriate responses to PPS audits and PV inspections, and ensure completion of resulting action plans and effectiveness checks
Ensure effective and appropriate PPS procedural documents are in place and maintained
Proactive member of ASCE LT responsible for driving culture and performance through role model shared leadership to achieve PPS strategies
Ensure appropriate and robust QC processes are in place to drive the quality and accuracy of safety submission documents
In Collaboration with QMS Business Process Owner ensure appropriate systems and processes are in place to support quality across PPS and Affiliate PV
Bachelor’s Degree or equivalent in related science field
10 years pharmaceutical industry experience; including a minimum of 5 years in pharmacovigilance.
5 years quality role experience required
5 years management experience, skilled to manage multiple personnel of varying experience
Significant leadership experience required to manage multifunctional responsibilities and influence at differing levels, able to identify, assess and manage business and compliance risks.
Successful candidate can be located in one of the following countries: Belgium, Germany, Italy, Netherlands, Sweden, France, Ireland, Spain.