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Astellas Pharma Associate Director , Pharmacovigilance Technology Strategy & Projects 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:

Applying a combination of PV experience and technological knowledge, this role is responsible for combining business needs and technological possibility and providing improvement.

Reports to the PV Technology Strategy and Project (PTSP) Team Lead, is a member of the PTSP team and contributes to the development and implementation successful execution of the PV mission, objectives and 3-5 year strategic plan.

This position assists in the establishment of mid- to long-term PV systems objectives and their successful implementation to ensure compliance with worldwide regulatory requirements and Astellas global policies. Specifically, this role will (1) identify new technical and software needs and solutions and ensure effective implementation; (2) develop and manage the PV IT strategy including safety database, roadmap and PV IT system budget; (3) oversee and implement PV technology projects including safety database upgrade/enhancement projects and (4) be a subject matter expert participating in complex projects. This role will facilitate translation of business needs into technical requirements and system configuration components in projects related to new systems or system upgrades.

Essential Job Responsibilities:

Strategy Development and Execution as assigned

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

The Associate Director is accountable for:

PV IT Strategy Development

  • Contribute to development and maintenance of mid- and long-term PV IT systems strategies which include safety database updates and integrity of associated systems as well as annual PV IT project plan and continuous improvement initiatives.

  • Develop and maintain a PV Information strategy in support of PV business objectives and enhance safety, compliance, and departmental efficiency and productivity.

IT Project Portfolio Management

Collaborate with Strategy & Planning and Information System to collect and assess business needs that require IT solutions from PV stakeholders, and develop and maintain comprehensive PV IT project portfolio/roadmap for all PV IT projects, including safety database upgrade/enhancement projects.

IT Project Oversight, Budget and Resource Management

  • Support PTSP TL to establish and maintain overall PV IT project budget and resource planning, which include upgrade or enhancement of existing system, implementation of new technologies and strategic projects.

  • Oversee PV IT projects/activities under the PVIM group's control as assigned.

IT Project Management, including safety database projects

  • Lead projects including relatively complex ones and ensure completion of the projects on schedule based on established processes and programs.

  • Lead or participate in the program with multiple sub-streams to implement processes and system changes in a coordinated manner.

  • Develop and maintain the global safety database to fully meet global regulatory requirements.

  • Lead or participate in cross-functional projects, including PV internal and M&D projects.

  • Ensure validated status of PV IT systems through implementation or upgrade projects.

Lead Innovations in PV Processes by Information Technology

  • Identify new technical needs and solutions based on input from business stakeholders, industry trends and available emerging technologies, assess feasibility of new technologies, plan and implement, as needed, important innovations in PV business processes and advances in PV information systems available in the marketplace, in use by competitors, and/or as required by regulatory agencies.

  • Propose improvements/efficiency gains for business processes and support process excellence using a technical perspective.

  • Participate in industry working groups to represent Astellas and contribute to technological development trends.

Support for audits and inspections

  • Participate in Pharmacovigilance audits and inspections as subject matter expert (where applicable) and contribute to the preparation for inspection. Responsible for quality investigations / root cause analysis and CAPA management when assigned as an issue or CAPA owner.

People & Organization Management

  • Support an environment to enable each member of the team to optimally operate in the matrix environment of PV and Astellas.

  • Responsible for the development and maintenance of effective collaborations with internal PV key stakeholders and functions, as well as of relevant external stakeholders.

Quantitative Dimensions:

  • Management of 3-5 major projects per year.

  • Applies technology to enhance safety and compliance, improve client service levels, increase job satisfaction, and augment productivity in PV.

  • These activities impact the entire PV organization and require in-depth subject matter expertise and strategy development to effectively manage complex technology projects to meet deadlines and quality metrics.

Organizational Context:

  • Reports to PTSP Team Lead.

  • May be assigned to coordinate the daily project work and/or operational activities of 5-10 team members/ outsourced support staff and/or allocation of adequate project resources to projects/activities under the PVIM group's control.

  • Interacts with PV IT staff globally, CIT, project managers, regulatory agencies, worldwide health authority inspectors, system support vendors, system delivery vendors.

Qualifications:

Required

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

  • Minimum of 7 years in the pharmaceutical or a related industry, preferably in a global, highly matrixed, and multicultural organization.

  • Minimum of 5 years' 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, and organization of internal metric reports to support process improvement initiatives.

  • Minimum of 3 years project management experience.

Skills/Knowledge

  • Understanding of PV business

  • Familiarity with regulations pertaining to adverse event reporting

  • Understanding of system validation

  • Skills of business analysis and requirement definition for PV IT systems

  • Safety Database and its configurations

  • Microsoft Office

  • Verbal and written fluency in English

  • Strong interpersonal communication skills and multi-cultural awareness.

  • Able to negotiate and build consensus for plans and priorities and develop effective working relationship through collaboration.

  • May require up to 15% international travel.

Preferred

  • Advanced degree (MA and/or PhD or related degree) is preferred.

  • Design and validation of IT reports

  • SQL Programming

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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