The Manager, PV COPE is responsible for the development and maintenance of excellence in global PV Quality,
Compliance, Audit and Inspection management and Process Improvement, in order to ensure oversight over the
PV Quality Management System, ensuring inspection readiness, as well as compliance with all applicable
worldwide pharmacovigilance regulations.
Collaborating with relevant PV and non-PV Astellas partners (e.g., Clinical and Research Quality Assurance, Regulatory
Affairs) for alignment with company-wide standards. Ensure oversight over the compliance, consistency and quality of
Pharmacovigilance processes by performing internal audits, deviation investigations and collecting, analyzing and
reporting on metrics, and driving continuous improvement of the PV System, so that PV represents best-in-class
Reports to the Group Lead of Compliance and Data Analytics or other PV COPE Group Leads. Is a member of the Compliance and Data Analytics, Process Improvement or Data Governance teams and contributes to the development, implementation and successful execution of the PV mission, objectives and 3-5 year strategic plan. Peers include other PI/QMS Managers, Process Managers, and other PV Operations teammembers.
Quality Cycle & Key Performance Indicators
- Establish and implement tools and processes, in close collaboration with other functions within PV, to identify and monitor compliance and quality metrics for the entire pharmacovigilance department, PV license partners and vendors for outsourced PVactivities.
- Ensure continuous monitoring on compliance, timeliness and quality metrics, including detected patterns and trends, in close collaboration with internal (other functions within PV and the JP- and/or EU-QPPV) and external stakeholders (Regulatory Affairs, Quality Assurance, license partners).
- Monitor compliance with inspection/audit response commitments and effectiveness checks.
- Provide feedback of (outsourced) PV case processing performance to functional groups at the appropriate level of detail and with the appropriate frequency to facilitate process improvement opportunities.
- Facilitate the Management Review process related to key performance indicators for PV processes.
- Support the maintenance of the PV Master File in collaboration with the EU-QPPV with regards to Compliance Metrics &KPIs
Inspection / Audit Readiness & Response
- Conduct regular internal assessments of PV processes for continuous improvement according to the established quality plan.
- Ensure coordination and support within PV (before, during and after) for external audits & inspections;
- Mentor and prepare PV staff for internal audits and external regulatory inspections.
- Support PV staff in local affiliate audits, license partner’s audits and local PV inspections.
- Implement best practices in audit / inspections management in close collaborations with Global and regional Quality Assurance functions.
- Analyze audit/inspection findings, identify appropriate corrective actions & preventive; and contribute to audit/inspection responses.
- Responsible for coordination and management of PV CAPA and deviations; provide guidance to the PV functions on the development, implementation and evidence collection.
- Ensure oversight on progress, evidence collection, negotiating timeline extensions with relevant PV, non-PV and external (e.g. License Partners) stakeholdersas required.
- Coordinate and support effectiveness checks, performed for applicable CAPAs, including following up on progress.
- Contribute to the development and ensure implementation of global best practices in Process Improvement Management in close collaborations with the PV functions, Global and regional Quality Assurance, and relevant global stakeholders.
- Perform trend analysis of aggregated inspection/audit findings to serve continuous improvements and to avoid repetitive findings.
- Ensure the systemic identification of Quality Risks (trends and patterns), in close collaboration with the business subject matter experts.
- Leading or supporting projects to improve regulatory compliance and continuously improve processes in order to ensure that Global PV represents best-in-class practices, in close collaboration with PV management and functional stakeholders.
- Contribute to Global PV training to ensure PV audit and inspections readiness and understanding on preparation of high-quality audit/inspection responses by all staff. Ensure collaboration and coordination with stakeholders in all PV functions including the Astellas affiliates.
- Develop, review, and maintain training materials related to audit and inspection readiness and audit/inspection response preparation across regions.
- Responsible for developing, reviewing and maintaining training materials related to Compliance and
Quality Key Performance Indicators.
- Support Data Governance function through use of processes and tools that will deliver high quality data for decisionmaking from both internal and external sources.
- Maintain awareness of functional Data Governance activities with potential downstream implications, align ongoing initiatives through performing impact assessments, raising issues and identifying and coordinating solutions
- Support PV staff of approximately 200 individuals by offering consultation, advice, and subject matter expertise.
- Assists with Regulatory inspection management activities and/or serves as Inspection SME in explaining PV compliance and quality monitoring processes and/or PV Quality Management activities.
- Responsible for ensuring global oversight over critical PV KPI, quality and compliance with regulatory requirements for submission of individual case safety reports, aggregate reports, risk management plans, corrective and preventative actions and deviations for local, regional and global products.
- These activities have major significance to the PV organization, and require in-depth subject matter expertise, strategic thinking and leadership skills to effectively manage complex operations resulting in regulatory controlled deliverables with external partners.
- Mentors and coordinates day to day operational activities of co-located COPE associates/ associate managers
- The Manager, PV COPE collaborates directly with PV Management, including the JP/EU QPPVs, PV and non-PV subject matter experts, and other Astellas partners, including Clinical and Research Quality Assurance, Regulatory Affairs, and Clinical Development Operations.