PV Reporting and Information Management Professional

General Information

Job Advert Title: PV Reporting and Information Management Professional

Location: Nihonbashi, Tokyo

Division: Regulatory Affairs and Pharmacovigilance

Employment Class: Permanent

Description

【About Astellas】

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. （HP:
Learn more about Astellas）

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

【募集の背景 / Purpose & Scope】

Applying a combination of business process expertise and technological knowledge, this role is responsible for combining business needs and technological possibilities and providing improvements and maintenance of excellence in PV Transformation and Technology (PV T&T). Responsible for strategy and development of excellence in the safety database and related PV systems critical for PV compliance (e.g., reporting tool, ICSR compliance management tool), and ensure integrity of the systems critical for PV compliance. Reports to the PV Reporting & Information Management Team Lead, is a member of the PV T&T team and 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 (1) developing a long-term reporting strategy and identify the best reporting solutions; (2) leading data & reporting governance activities; (3) designing, developing and enhancing complex reports and custom report, including global and Japan periodic reports; (4) maintaining RAPV technology system validation and business continuity/risk management (5) enabling cross-functional data integration; (6) helping business team design the best approach for data analysis.

【職務の内容 / Essential Job Responsibilities】

（雇入れ直後）

Strategy Development and Execution:

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

The PV Reporting and Information Management Professional is accountable for:

PV Data and Reporting Strategies

• Lead development and maintenance of a long-term reporting strategy and identify best reporting solutions

that support various PV activities as well as Astellas DigitalX strategies

• Participate in or lead the development and maintenance of a data accessibility strategy to ensure the

optimal use of data and to support advanced data analysis which utilizes data stored in multiple

technology solutions

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 technology 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.

• Work with business team to develop or enhance various periodic report templates to meet the regulations.

• Help business team design the best approach for analysis of safety data, by using data expertise.

• Oversee and address various reporting issues raised by end users. If needed, work with technology

vendors and DigitalX team to fix issues.

• Oversee the assessment of impact from system changes or major process changes on existing reports.

• Participate in 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 technology systems.

• Responsible for quality investigations / root cause analysis and CAPA management when assigned as an

issue or CAPA owner.

• Collaboration and oversight of outsourced reporting vendor to ensure timely and accurate report

production and delivery of outputs.

• Collaboration with Global Safety Database vendor to ensure reporting system and tools are working

properly and outputs are generated in a timely and accurate manner.

Ensuring the validation status of critical reports from PV IT systems

• Work with DigitalX and Validation Lead to ensure optimal validation status of critical reports from PV

technology systems.

• Oversee the development of validation protocols, user acceptance tests, and OQ/PQ scripts for reports

from PV technology systems.

• Ensure Global Safety Database Computer System Validation (CSV) documents for reports from PV

technology systems are maintained appropriately.

Establishment and Improvement of PV reporting solutions

• Establish and improve technology systems and tools required to produce various line listings and

summary tabulations that can meet complex business needs.

Process Improvement

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

technical perspective.

• Lead process excellence in safety data and reporting support.

Establishment of Data and Reporting Governance

• Lead and support the establishment and maintenance of the data and reporting governance.

• Manage data transfer in validated condition for acquisitions/divestitures.

• Identify technological opportunities for reporting and facilitate solutions by influencing vendors.

People & Organization Management

• Support an environment to enable each member of the PV Reporting and Information Management Team

to optimally operate in the matrix environment of RAPV and Astellas.

• Assist in training junior team members for appropriate growth in technical skills.

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

（変更の範囲）

会社内での全ての業務

【就業環境に関する要件 / Specific Physical or Environmental Requirements】

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

【応募要件 / Qualifications】

＜必須 / Required＞

Education

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

Experience

• Minimum of 12+ years in the pharmaceutical or a related industry, preferably in a global, highly matrixed, and

multicultural organization.

• Minimum of 6 years of safety database-related global project management experience.

Skills/Knowledge

• Understanding of PV business including case processing workflow

• Familiarity with regulations pertaining to adverse event reporting

• Understanding of system validation

• Skill of business analysis and requirement definition for safety data systems

• Safety database and its configurations

• Design and validation of IT reports

• Project management skill

• Microsoft Office

• Verbal and written fluency in English

• May require up to 10% international travel.

＜歓迎 / Preferred＞

• Advanced degree is preferred.

• Experience managing a global project including Japan.

• The preferred location for this position is Northbrook, IL, Leiden, Netherlands, or Tokyo, Japan.

• SQL programming.

【応募書類 / Application Documents】

和文履歴書・和文職務経歴書・英文レジュメ

Both Japanese and English Resumes are needed

【選考プロセス / Selection details】

書類選考 → 1次面接 → 最終面接

※変更の可能性もございますので、予めご了承下さい。

CV screening → First interview → Final interview

*Please be advised that there might be a change in the process.

【勤務地 / Location】

（雇入れ直後）

東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo

（変更の範囲）

会社の定める事業場および自宅

【勤務開始日 / Start Date】

応相談

Will be decided according to the candidate's flexibility

【契約期間 / Contract Duration】

期間の定めなし

Not limited to specified period

【試用期間 / Probation Period】

試用期間原則なし

No probation period in principle

【給与 / Salary】

①基本給：当人の経歴・技術・技能等を考慮して決定

②裁量労働制の場合：裁量労働手当として職務グレードに応じて50,000～100,000円支給

③フレックスタイム制の場合：月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給

①Base salary: will be decided by the candidate's experience, skill and capability.

②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000～100,000yen, based on the Grade)

③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.

【昇給 / Salary Raise】

有り

【賞与 / Bonus】

有り

【諸手当 / Allowance】

裁量労働手当、住宅手当、通勤手当 等

Discretionary work allowance, Housing allowance, Commutation allowance, etc.

【勤務時間 / Working Hours】

8:45～17:45（月～木）、8:45～16:00（金）、専門業務型 裁量労働制

裁量労働制の場合、所定労働時間を働いたものとみなす

8:45～17:45（Mon～Thu）、8:45～16:00（Fri）

Discretionary Work System

【休日 / Holidays】

完全週休２日制（土曜・日曜）、祝日、5月1日、夏季、年末年始

Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays

【休暇 / Vacation Leave】

年次有給休暇、育児休業制度、介護休業制度 等

Annual paid leave, childcare leave system, nursing care leave system, etc.

【福利厚生 / Welfare】

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等

Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System

【アステラス製薬 採用サイト/ Career web site】

https://re-jp.astellas.com/jp/recruit/newgraduates/

For more information about Astellas, please visit our career web site.

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

【What awaits you at Astellas? 】

•Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.

•Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

•Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.

•A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

【Our Organizational Values and Behaviors】

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.