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Astellas Pharma Manager PV Data Assurance in Northbrook, Illinois

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 .

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:

  • Responsible for development and maintenance of excellence in Regional 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 Process functions, regions and case processing vendor(s).

  • Reports to the PV Process Data Assurance Team Lead, is a member of the Data Assurance Management Team and contributes to the development, implementation, and successful execution of the PV objectives and 1--3-year operational plan, supporting the overall PV Process and PV mission.

  • Responsible for ensuring the quality of (contracted) work delivered under the PV Process regional function, which directly impacts the effective management of the safety profile of Astellas development compounds and marketed drugs.

  • Leads the regional PV process data assurance group ensuring high quality operational data and a variety of QC and training activities associated with ICSR and literature processing.

  • Works extensively with vendor personnel and PV process staff within and across the regions to ensure the high data quality required to support the ongoing assurance of the safety profile of Astellas products.

  • Supports inspection readiness activities and fulfils the role of a key SME for topics associated with in-house and outsourced operational case safety aspects of PV Process activities for case processing, literature search and assessment.

Essential Job Responsibilities:

Strategy Development and Execution

  • Leads and oversees the PV Process Regional Data Assurance team consisting of PV Process Data Assurance team members, to support global policies and standards to ensure case consistency and quality at the operational level.

  • Responsible for implementation and execution of various PV Process operational support tools to ensure quality and consistency.

  • Supports in creating and maintaining global standards 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).

  • Contributes to global (cross-functional) process improvement initiatives and projects impacting operational aspects of ICSR reporting, support tools and associated activities.

  • Participates, with the Data Assurance Team Lead and as a member of the Data Assurance Management Team, in the successful execution of global PV Process vision, mission, objectives and plans.

  • Contributes to the successful implementation of annual Data Assurance strategic goals and objectives.

The Regional PV Process Data Assurance Manager is responsible for:

ICSR Processing & Literature Management:

  • Implementing global ICSR case processing policies and strategies at the regional level

  • 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 within the region.

  • First line of decision-making on operational case processing matters and for approval of case corrections and inactivations.

  • Performing or initiating case corrections as needed, and for deciding on the type of corrections required.

  • Provision of SME services for ICSR processing queries by the vendor.

  • Provision of PV Process support in PQC assessment and evaluation.

  • The correct content of training materials.

  • Ensuring and maintaining excellence, consistency, completeness, and accuracy in case processing.

  • Building and maintaining close relationships with Medical & Data Assurance team members and vendor staff.

  • Ensuring backup and support of Data Assurance Team Lead to support continuity of workflow management.

Quality, Data Assurance & Business Information management

  • Represents Regional PV Process 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.

  • Supports planned deviations or CAPAs and global quality improvement initiatives associated with operational aspects of ICSRs and related activities.

  • Ensures correct decision-making on and execution of study-case unblinding (SUSAR unblinding s well as endof study unblinding) by performing appropriate review and providing advice.

  • Serves as liaison with regional DSOs on ICSR matters and ensures appropriate information flow (ICSR collection, outbound FUs etc.) and quality thereof.

  • Cooperate with the Medical Assurance team and the colleagues in the other regions to ensure global consistency

Training:

  • Responsible for training and specialist education of Vendor and PV Process staff in assigned region.

  • Represents PV in large (cross-) functional PV Process training sessions promoting pharmacovigilance awareness and providing PV Process regional/specialist education across internal and external audiences.

  • Providing specialist education to PV, non-PV staff and vendor staff performing PV process activities.

  • Presents PV Process overview to new Astellas employees in Regional Data Assurance.

People & Organization Management

  • Contribute to the effective implementation of optimal organizational structure(s) which maximizes on the use of resources regionally, taking the global impact into consideration, and reflects business needs and conditions.

  • Develops an environment to enable each member of Regional Data Assurance function to optimally operate in the matrix environment of PV and Astellas.

  • Manages the function and its people, through successful recruitment, performance management, development planning and retention of a highly performing team.

  • Effectively delegates responsibilities to achieve Data Assurance team 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.

  • Responsible for the development and maintenance of effective collaborations within the Medical & Data Assurance team and other PV (Process) functions, as well as of relevant external stakeholders:

  • With Development Operations on case unblinding

  • With the global case processing vendor to ensure appropriate quality of regional cases processed

  • With Regulatory Authorities, license partners and internal functions in providing expertise to ICSR processing-related matters

Quantitative Dimensions:

  • Ensures complete and accurate processing of individual safety case reports for all Astellas products at the regional level. Globally over 150.000 case versions are processed annually with an average annual increase of appr. 15%.

  • Assists with Regulatory inspection management activities and serves as Inspection SME in explaining the various ICSR activities as well as medical aspects of case evaluation.

  • These activities have major significance to the PV organization and the company at large and require in-depth subject matter expertise and leadership skills to effectively manage complex operations resulting in regulatory controlled deliverables with external partners.

  • Regionally responsible for process areas that can impact development/regulatory review/acceptance as well as product maintenance and create significant delay or additional costs.

Organizational Context:

  • Reports to the PV Process Data Assurance Team Lead. Peers include other Regional PV Process Data Assurance Managers.

  • The Regional PV Process Data Assurance Manager will be responsible for managing the Regional PV Process Data Assurance group in the assigned region (expected to comprise between 2 and 10 team members depending on the region).

  • Cooperate closely with Medical Assurance team members as well as ICSR/literature processing vendor medical staff.

Qualifications:

Required

  • 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 PV Process 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

Skills and competencies:

  • Demonstrates leadership to ensure case processing, (medical) evaluation and case quality are always maintained at highest standards

  • Demonstrates effective leadership and management skills, including ability to lead and manage a multidisciplinary team

  • Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus on medical matters and able to develop effective relationships through collaboration.

  • Demonstrated ability to resolve conflict situations, think tactically, and build consensus across the global organization. Able to generate insights and leverage learnings at the individual team and functional level.

  • Able to lead meetings, present orally and interact with external bodies

  • Excellent communication and presentation skills in English (written and spoken)

  • Ability to leverage all available resources internally and externally

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

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Category Pharmacovigilance

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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