Associate Director, PV Technology Strategy & Projects

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

About this job:

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 significant experience in 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.

Key Activities are noted below:

• 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.
• 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.

Experience and Knowledge:

• Extensive experience in the pharmaceutical or a related industry, preferably in a global, highly matrixed, and multicultural organization.
• Solid experience in 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.
• Good experience in project management.

Qualifications:

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

Additional information:

• Hybrid work.
• This position is based in the UK, or in the Netherlands or in Ireland.
• Full time.
• May require up to 15% international travel.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.