PV Reporting and Information Management Team Lead

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Astellas' Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.

The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.

Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company's strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients

Purpose And Scope
Reporting to the PV Transformation and Technology (PV T&T) Group Lead, the purpose of this role is to ensure the development, maintenance, and improvement of operational excellence in PV system and business operations globally. Applying a combination of PV experience and technological knowledge, this role is responsible for combining business needs and technological possibilities and providing improvements and maintenance of excellence in PV Information Management. As a member of the PV Transformation and Technology team this role contributes to the development and implementation successful execution of the PV mission, objectives and a 3-5-year strategic plan. This position is responsible for leading PV Reporting and Information Management (RIM) Team. This strategic role will maintain mid- to long-term PV systems objectives and their improvement to ensure compliance with worldwide regulatory requirements and Astellas global policies. Specifically, this role will:

• Develop a long-term reporting strategy and identify best reporting solution,
• Ensure timely development and delivery of various high-quality outputs from PV IT systems to support various PV activities
• Help business team design the best approach for data analysis;
• Develop validation strategies for PV IT systems including new technologies
• Lead or participate in cross-functional projects that require safety data or reporting expertise, including cross-functional data integration.

Responsibilities And Accountabilities
Strategy Development and Execution

• Participates in the successful execution of the PV vision, mission, objectives, and plans. Contributes to the successful implementation of annual PV Transformation and Technology strategic goals and objectives.

The RIM Team Lead Is Accountable For
PV data accessibility and reporting strategy:

• Develop and maintain a long-term reporting strategy and identify best reporting solutions that support various PV activities as well as Astellas Information Systems strategies.
• Develop and maintain a strategy for PV data governance to ensure the optimal use of data and to support advanced data analysis which utilizes data from multiple IT systems.

Validation strategies for PV IT systems

• Work with Quality Assurance (QA) and DigitalX (DX) to develop strategic vision for validation activities needed for PV related systems and validation approach for new/future technology changes (cloud hosted systems, RPA, AI, automation) to ensure agile, risk-based methodologies for validation.

Management and improvement of reports from PV IT systems to support various PV activities.

• Oversee development and execution of various high-quality outputs from PV IT systems, including complex reports, and ensure the quality and timeliness of deliverables in support of business processes and in response to HA questions in the three regions, by utilizing a deep knowledge of systems and data.
• Ensure timely delivery of line-listings/summary tabulations for periodic reports to maintain the high periodic report compliance rate.
• Ensure the team can help business team design the best approach for data analysis.
• Oversee and address various reporting issues raised by end users. If needed, work with DigitalX team and software vendors to fix issues.
• Oversee the assessment of impact of system changes or major process changes on existing reports.
• Ensure the availability of the RIM team members to support Pharmacovigilance audits and inspections as subject matter expert (where applicable) and contribute to the preparation for inspection by ensuring availability and/or extract of requested data from the Global Safety Database and other PV IT systems.
• Responsible for quality investigations / root cause analysis and CAPA management when assigned as an issue or CAPA owner.

Oversight of the validation activities and improvement of System Life Cycle (SLC) process for PV IT systems

• Provide support and oversight of all SLC validation activities across PV IT systems for daily operational changes as well as key PV IT projects.
• Work with relevant functions (e.g. PVQA, ESQA, and IS Risk & Compliance) to ensure continuous improvement of SDLC maintenance / review procedures for PV IT systems.

Develop and implement a validation plan for the PV IT systems including Global Safety Database

• Oversee development and implementation of a validation plan for the global safety database and other PV IT systems to fully meet global regulatory requirements.
• Work with DigitalX and software vendors to ensure the optimal validation status of PV IT systems and ritical reports through development and maintenance of system validation standard approach for PV IT systems.
• Ensure Global Safety Database Computer System Validation (CSV) documents are maintained appropriately during safety database change management process.
• Maintain the safety data system to be compliant with the FDA's Part 11 and related worldwide regulations.

Establish and improve of PV reporting solutions

• Establish and improve IT systems to produce various line listings and summary tabulations that can meet complex business needs.

Data governance and integrity

• Establish and maintain data and reporting governance in PV IT systems.
• Lead a cross-functional initiative of M&D-wide data integration as a PV representative.
• Establish a mechanism for data integration and sharing M&D-wide through M&D Data Lake.
• Ensure data integrity in PV IT systems.
• Lead and manage data transfer in validated condition for acquisitions/divestitures.

Process Improvement

• Consult and facilitate implementation of best practices in the industry.
• Propose improvements/efficiency gains for business processes and support process excellence using a technical perspective.
• Proceed with process excellence in safety data and reporting support.

Establishing Globally Integrated Supporting Office Model

• Maintain oversight and manage necessary workforce and skillsets available.
• Lead / participate in the worldwide user conferences of key safety data systems.
• Identify technological opportunities for reporting and facilitate solutions by influencing vendors.

People & Organization Management

• Responsible for the effective implementation of an optimal organizational structure(s) that maximizes the use of resources globally and reflects business needs and conditions.
• Develop an environment to enable each member of the DMRA Team to optimally operate in the matrix environment of PV and Astellas.
• Manage the RIM Team and its people through performance management, development planning and retention of a high-performing team. Effectively delegate responsibilities to achieve the PV Transformation and Technology goals and effectively develop and align 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.
• Responsible for the development and maintenance of effective collaborations with internal PV key stakeholders and functions, as well as of relevant external stakeholders.

Required Qualifications
Education

• BA/BS in computer-related field or higher education in healthcare discipline.

Experience

• Minimum of ten years in the pharmaceutical or a related industry.
• Experience in leading a project global, highly matrixed, and multicultural organization.
• Minimum of five years of experience managing complex Clinical Development or Pharmacovigilance information systems, including system validation, management of business continuity/disaster recovery, responsibility for the timeliness, accuracy, high quality, integrity, and security of global safety databases, organization of internal metric reports to support process improvement initiatives.
• Minimum of three years of safety database-related global program management experience.
• Minimum of one year in personnel management.
• Minimum of one year in vendor management.

Skills/Knowledge

• Understanding of PV business including case processing workflow
• Familiarity with regulations pertaining to adverse event reporting
• Understanding of system validation
• Advanced skill of business analysis and requirement definition for safety data systems
• Safety database and its configurations
• Design and validation of IT reports
• Advanced project management skill
• Microsoft Office
• Verbal and written fluency in English
• Strong interpersonal communication skills and multi-cultural awareness.
• May require up to 15% international travel.

Preferred Qualifications

• Advanced degree in science or technology field or equivalent is preferred
• Experience managing IT systems

Category RAPV Operations

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EOE including Disability/Protected Veterans