Director, PV Process Interface Management
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Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at [Register to View] .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
In coordination with the PV process leadership team, responsible for development and maintenance of excellence in PV Process Management. Interface to Astellas organization for PV information needed to support and fulfill PV activities, including safety data collection needs. The Director reports to the PV Process Interface Management Lead and contributes to the development, implementation, and successful execution of the Global PV Process objectives and 1-3 year operational plan, supporting the overall GPV mission.
Contributes to establishment of contract parameters, collects key metric information, and identifies/implements continuous improvement initiatives as appropriate.
In coordination with PV Process Interface Management lead, responsible for regulatory compliance and inspection readiness for the relevant area. Works extensively with Commercial vendor personnel and PV process staff to ensure forms, data collection, timelines, training, reconciliation, and global standards are adhered to and maintained. Ensures performance and operations of PV process Interface activities and contributes as an expert influencer in PV Process both internal and external to Astellas. This individual is an expert in product modalities, applicable regulatory intelligence and the application of PV science.
Essential Job Responsibilities:
Strategy Development and Execution
Contribute to development and implementation of 1-3-year PV Process specific objectives and plans as part of the overall Global PV Process strategy and operational plans. Participates in the successful execution of Global PV Process vision, mission, objectives and plans. Contributes to development and the successful implementation of annual PV Process Management strategic goals and objectives.
The Director PV Process Interface Management Lead (level 4), is accountable for:
- Co-Develop and execute strategy for Global PV Process; ensure all local and global regulatory requirements and guidelines for PV activities and data needs, are fulfilled by PV data collection strategies.
- Implement global ICSR policies, strategies and global standards.
- Contributes towards the development of the pharmacovigilance PV Process and Medical Review & Analysis training curriculum and is responsible for the correct (medical/technical) content of training materials.
- In coordination with PV Process leadership team, collaborate to ensure capacity management of global PVP strategies and processes in order to maintain critical business continuity in all circumstances.
- In coordination with PV Process Interface management l lead, maintains up-to-date oversight and knowledge of all regulatory reporting requirements to Competent Authorities (EMEA: over 100 countries; JP/Asia: appr. 10-20 countries; Americas: appr. 10 countries); Advises PV Process Interface management lead of possible impact of any new or revised regulations.
- Maintains up-to-date knowledge of regulatory reporting rules and Astellas product information and local/global status.
- In coordination with PV Process management lead, maintains up-to-date oversight and knowledge of all regulatory requirements and guidelines for intake, collation, evaluation, review and reporting of safety information in the regionally and globally (EMEA: over 100 countries; JP/Asia: appr. 10-20 countries; Americas: appr. 10 countries); Advises PV Process management regional lead of possible impact of any new or revised regulations or guidelines.
- Ensure PV requirements are incorporated in protocol design and/or Safety Management Plans for all clinical studies * Ensure PV requirements for collection and reporting of safety information for non-interventional studies, patient support programs, etc. are met ; includes forms, standard contract language; reconciliation.
- Ensure all customer-facing staff (clinical, medical, as well as other) are aware of requirements for intake of safety information in region.
- Ensure regional implementation and maintenance of Business Partner/SDEA specific PV Process requirements and relationship management.
- Build and maintain close relationships with DSOs, Regulatory Affairs, Clinical and Medical Affairs functions regionally and globally.
Product Quality Complaint Management:
- Build and maintain close relationships with QA, Regulatory Affairs, Product Supply and Manufacturing functions regionally and globally.
- Ensure operational execution of Product Quality Complaint processing and evaluation. (Triage, Forwarding, Investigation, Reconciliation and Reporting).
- Provide Medical and PV Process support to PV Process Global Management and GMS/GSS in PQC assessment and evaluation.
Quality, Data Assurance & Business Information management
- In coordination with PV Process Interface Management Lead, implement global QC policies and strategies at the regional and global level
- Contributes to operational execution of QC of Safety Reporting Plans, contracts.
- In coordination with PV Process Global Management ensure self-inspection and QA, Deviation Investigation and CAPAs, and Quality Improvement activities
- In coordination with PV Process Interface Management lead, establish, maintain and validate and execute the best practice of PV Process activities.
- Contributes to drive business regulatory compliance and inspection readiness requirements within assigned region through directed interactions and feedback from Global PV Process management, GPV personnel and collaboration stakeholders.
- Ensure preparation of responses to internal and external audits and inspections and implement agreed upon action plans;
- In coordination with PV Process Interface Management lead, represents GPV Interface Management in Inspections, PV audits and non-PV audits (GMP/GCP).
- Ensure root cause analysis are concluded and appropriate corrective and preventive measures taken for compliance issues related to Interface Management.
- Support PV Process Global Management in creation and maintenance of Conventions, MedDRA coding and synonyms and auto-labelling.
- Support PV Process Global Management in business information management (e.g. KPIs) and oversees regional operations to ensure Astellas standards are maintained/exceeded.
- In coordination with PV Process Interface management lead, ensure relevant training (PV Processes and Systems) of Vendor and PV Process staff in assigned programs
- In coordination with PV Process Global Management, Affiliate Management and PV Training, ensure training of other and Non-PV staff in assigned region regarding PV Awareness and Customer-facing PV training
- In coordination with PV Process Interface Management lead, represents Global PV in large (cross-) functional PV Process training sessions promoting pharmacovigilance awareness and providing PV Process regional/specialist education across internal and external audiences.
Vendor & Outsourcing Management:
- In coordination with PV Process Global Management and PV process management regional lead, ensures regional vendor evaluation and selection, on boarding/training of outsourced resources, issue resolution and escalation, and provides primary interface with the GPV Teams
- Contributes to operational vendor management within assigned region to maximize the quality, compliance and (cost) effectiveness of the work team outputs.
- Contributes to implement an effective collaboration model and relationship management for GPV outsourced work
- Support PV Process Global Management Vendor management and governance in the development of short and long term business objectives for delivery of external business partnered services
- Ensure regional vendor compliance to contract terms.
- Forecast demand management for resources
- In coordination with PV Process management regional lead, keep PV Process Global Management team apprised of business needs and financial spend with regional vendors
People & Organization Management
In coordination with PV Process Interface Management Lead, the Director is responsible for the effective implementation of optimal organizational structure(s) which maximizes on the use of resources globally and reflects business needs and conditions. Develops an environment to enable each member of the PV Process Interface Management function to optimally operate in the matrix environment of GPV and Astellas.
In coordination with PV Process management regional lead, manages the function and its people, through successful recruitment, performance management, development planning and retention of a high performing team. Effectively delegates responsibilities to achieve Regional PV Process Management goals and effectively develops and aligns individuals to the best of their abilities, while ensuring optimal oversight and supervision to ensure goals are achieved and appropriate growth in technical, leadership and team membership skills.
In coordination with PV Process management regional lead, responsible for the development and maintenance of effective collaborations with peers in Global PV process and internal GPV key stakeholders and functions, as well as of relevant external stakeholders:
- With the Lead of Affiliate Management, responsible for close alignment of regional affiliate activities related to PV Process functions
- With the Lead of Training for close alignment of training activities related to PV Process functions
- With GCOM and Procurement for vendor and contract activities related to regional PV Process functions
- With GMS/GSS for managing of safety issues in region
- Ensures Astellas collects all relevant safety information necessary to fulfill PV regulatory activities. Globally over 150.000 case versions are processed annually with an average annual increase of appr. 15%.
- Contributes to benchmark compliance aiming to 100% reporting compliance of globally appr. 50.000 submissions annually
- In coordination with PV Process management regional lead, responsible for company compliance with regulatory requirements for submission of individual case safety reports for local, regional and global products within region
- In coordination with PV Process management regional lead, assists with Regulatory inspection management activities and serves as Inspection SME in explaining GPV outsourcing processes and PV Process activities.
- These activities have major significance to the GPV organization and the company at large, 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.
- In coordination with PV Process management regional lead, establishes, monitors and works within allocated budget/outsourcing contract that exceeds 10 million dollar.
- In coordination with PV Process management regional lead, responsible for technical, medical and/or process areas that can impact development /regulatory review/acceptance as well as product maintenance and create significant delay or additional costs.
- Reports to the PV Process Interface Management Leader. Peers include PV Process Management Leaders, as well as members of the GPV Extended Management Team.
- The PV Process Interface Management Lead (Level 4) will be responsible for managing the relevant global PV Process group. This position is newly defined and the exact number of direct / indirect reports is yet to be determined. The position is expected to supervise direct or indirect (either in-house or through FSP) an organization of around 10-20 FTE.
- Cooperate closely with Astellas' EU and JP QPPV and the other PV Process Global and Regional Management Leads.