PV System Process Governance Professional

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

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 www.astellas.com .

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 System Process Governance (PV SPG) Team Lead, the purpose of this role is to ensure the development, maintenance, and improvement of operational excellence in PV system and business operations globally.

This position is responsible for

• maintenance and improvement of PV IT systems including safety database and process automation solutions supported by new technologies;
• oversight of outsourcing vendor supporting PV IT system operations;
• maintenance of PV IT system management processes;
• representing PV Transformation and Technology (PV T&T) in cross-functional discussion to identify solutions to address new regulatory requirements or process enhancement.

This role is responsible for decisions regarding continues system enhancement requirements, bringing visibility to operational activities and effectiveness (metrics and analytics) and cross-functional process improvement with the objective of streamlining and standardizing the PV system landscape and ensuring the accuracy and reliability of safety information. Liaises with peers across the industry to determine and establish best practice within Astellas.

Responsibilities and Accountabilities:

• Translates business requirements that occur in daily operations into system configuration components.
• Represents PV T&T in cross-functional discussion to identify solutions to address new regulatory requirements or process enhancement.
• Ensures that safety database system configurations are compatible with regulatory requirements and corporate strategy.
• Works with Digital X and software vendors to ensure all PV IT systems are operational and compliant with regulatory requirements and company validation policies.
• Oversees the development of Computer System Validation documentations, including Operational Verification Test scripts and Performance Verification test scripts for PV IT systems.
• Maintains the validated status of safety database and associated systems and ensure adequate maintenance of reference data and configurations to support business continuity/risk management.
• Maintains the safety data system to be compliant with the FDA’s Part 11 and related worldwide regulations.
• Participates in Pharmacovigilance audits and inspections as subject matter expert representing PV T&T (where applicable), and contribute to the preparation for inspection by ensuring availability and/or generation of adequate information from the Global Safety Database and peripheral applications.
• Responsible for quality investigations / root cause analysis and CAPA management for PV IT systems relevant findings.
• Serves as the primary contact point for regional safety database users and stakeholders within PV.
• Maintains and improves other PV IT systems to continue to meet various regulatory requirements in all countries where Astellas has responsibility.
• Ensures the business objectives of timeliness, accuracy, high quality, integrity, and security of the global safety database, including electronic submissions to regulatory authorities.
• Oversees daily safety database operations, including business configuration changes, development and execution of various outputs, and ensure the quality and timeliness of deliverables in support of business processes and in response to HA questions.
• Assesses the appropriateness and potential impact of safety database change requests to ensure the continued compliance with worldwide regulations, the validity of the database and the quality of outputs.
• Oversees the assessment of impact of system changes on downstream activities and impact of major process changes on safety database platform.
• Oversees global safety database incidents, and address incidents raised by business stakeholders. If needed, works with DigitalX and software vendors to fix issues.
• Ensures Global Safety Database Computer System Validation (CSV) documents are maintained appropriately during safety database change management process.
• Drives process efficiency by supporting implementation of electronic and digital capabilities where possible including PV Process change management/control towards electronic and digital transactions
• Enables compliance in processes and systems with both internal and external procedure and guidelines/legislation
• Measures and evaluates processes and standards with appropriate Metrics, and introduces and maintains best practices leveraging methodologies such as Lean Six Sigma
• Participates in and leads industry working groups to represent Astellas, often in collaboration with other PV members including PV operations, and PV Regulatory Intelligence colleagues
• Serves as PV Process Workstream Lead or Co-Lead in cross-functional projects where IT systems or changes thereof are implemented.
• Works with PV Process Leads as well as cross-functionally to determine URS for new implementation projects
• Interacts with team leads in these projects that oversee process development, change management and training activities.
• Serves as a delegate of the Business Process Owner of PV systems.

Governance of system validation

• Collaborates with PV Validation Lead and contributes to development, implementation, and maintenance of the relevant processes to ensure validated state of the PV systems is continuously maintained.
• Oversees business process validation testing in face of multitenant system environment.
• Plans and coordinates business testing of configuration concepts prior to generating change requests.
• Reviews all suggested process changes in PV Process for technical impact and regulatory compliance prior to implementation in cooperation with PV operations.
• Serves as the liaison to PV Interface Management, PV Case Management, DigitalX and other Planning and Administrative functions on a variety of topics including platform strategies and technology roadmap prioritization.

Business Solution

• Responsible for implementing the technological solutions and providing support for business process solutions.
• Ensures relevant issues and solutions to be an organizational knowledge and reflected in the future system design
• Performs business analysis of systems and associated procedures to establish best practice.
• Manages staff and consultants as well as mentors junior staff members on regulatory processes, systems and standards on a global basis with resources located in more than one continent; develops team by recruiting, coaching, assessing and guiding staff members.
• Creates and maintains good working relationships with adjacent functions such as RA, MA and Development

Required Qualifications:

• BS/BA degree or higher is required in a science or technology field
• In depth understanding of Case Management process and requirements as well as > 5 yrs experience of maintenance and support PV related IT systems and business processes.
• 12 years’ experience in pharma industry preferably including experience in a PV Process or Operations role
• 5 years’ experience managing people and/or teams
• Strong communication and collaboration skills
• Ability to multi-task across multiple projects and deliverables
• High integrity to maintain confidential and proprietary information

Preferred Qualifications:

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