Job Description

Purpose and Scope:


Responsible for development and maintenance of excellence in Data Assurance, with a focus on operational aspects of individual case safety report (ICSR) and literature global standards and drives quality, consistency and operational efficiency across the Astellas PV Case Management functions, regions and case processing vendor(s).



Responsibilities and Accountabilities :



ICSR and Safety Information Processing


Implementing global ICSR case processing policies and strategies Creating and maintaining conventions, tools and processes for non-medical review and assessment of ICSRs and literature, including case intake, data entry (including the case narrative), unblinding, quality control and monitoring, when performed by the case processing vendor(s). Management of the receipt of incoming safety information, including co-licensor, partner, affiliate and third party case specific communications.

Quality, Data Assurance, Training & Business Information management:


Represents PV Case Management team in Inspections, PV audits and non-PV audits (GMP/GCP) as an SME on case quality matters. Responsible to justify the Astellas opinion regarding individual case assessment to external bodies (e.g. during regulatory inspections and in responses to authority requests) Supports the review of key compliance and quality metrics associated with the assessment of ICSRs on an ongoing basis, to drive continuous in-house and outsourced quality improvement initiatives.

Capacity Management & Oversight, and Budget:


Support capacity management of global case flow performed in Astellas by accurate forecasting for developmental and post-marketing activities and ensuring business continuity to ensure timely adaptation of resource planning Support to evaluation and selection, on boarding/training of outsourced resources, issue resolution and escalation

Maintaining Regional Knowledge, Intelligence & Accountability:


Ensure continuous awareness, proactive awareness, regional presence, and knowledge in this field remains essential, particularly for USA, and EU/EEA in order to absorb accountabilities and responsibilities in RA PV Operations are based on country, region, authority, institution regulatory requirements and guidance Contributes to maintain up-to-date oversight and knowledge of all regulatory requirements and guidelines for intake, collation, evolution, review and (regulatory) reporting of safety information

People & Organization Management:


Contribute s to the effective implementation of optimal organizational structure(s) which maximizes on the use of resources, taking the global impact into consideration, and reflects business needs and conditions. Develops an environment to enable each member of PV Case management team to optimally operate in the matrix environment of PV and Manages the function and its people, through successful recruitment, performance management, development planning and retention of a highly performing

Strategy Development and Execution



Leads and oversees the PV Data Assurance regional team in order to support global policies and standards to ensure case consistency and quality at the operational level. Responsible for implementation and execution of various PV Case Management operational support tools to ensure quality and consistency.

Training:

Responsible for training and specialist education of Vendor and PV Case Management staff in assigned Represents PV in large (cross-) functional PV Case Management training sessions promoting pharmacovigilance awareness and providing PV Case Management regional/specialist education across internal and external Providing specialist education to PV, non-PV staff and vendor staff performing PV Case Management Presents PV Case Management overview to new Astellas employees in Data Assurance.

Required Qualifications:


Minimum BA/BS, preferably with an advanced professional degree


Minimum of 5 years relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development, including extensive leadership experience, including ability to lead and manage a global, multidisciplinary teams


In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations


In-depth knowledge and understanding of ICSR processing regulatory requirements and guidelines in


assigned region


Proven experience with establishing and maintaining (GxP) Qualities Management System.


In depth personal experience and understanding of Process Management, Standards &Training as they apply


throughout the entire pharmaceutical compound/product life cycle