Pharmacovigilance Scientist

General Information

Job Advert Title:

Pharmacovigilance Scientist

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】
The purpose of the Pharmacovigilance Scientist (PVS) role is to support the Japan Safety Officer (JSO) and/or
Global Safety Officer (GSO), or other PVSs, as applicable, with primary responsibility for signal detection and case
series data analysis under the guidance of the JSO/GSO.

【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
Act as key member of the PV Product Responsible team for his/her assigned products, and under the close
supervision of the JSO/GSO, the PVS will:

• Collaborate with the JSO, GSO, or other PVSs, as applicable, in coordinating medical-scientific monitoring and
assessment of the safety profile of one or more Astellas products.

• Assist JSO, GSO or other PVSs, as applicable, with the preparation of meeting materials/presentations
for PV product meetings such as but not limited to:

– Product Responsible Teams

– Core Clinical Development and Core Medical Teams

– Global Development Safety Management Teams

– Joint Safety Management Teams

– Core Teams (Extended)

– And Global Medical Affairs Core Medical Team

The PVS may also, as requested, attend these meetings with the JSO/GSO.

• The JSO/GSO owns the strategic priorities and drives implementation, while the PVS supports and contributes
as necessary applying knowledge of Therapeutic Area, regulatory science, and signal surveillance to manage
characterization of the compound/product safety & benefit-risk profile. These activities will include, but not be
limited to:

– Supporting the JSO/GSO, as applicable, in the development of the initial safety surveillance

development strategy and leading subsequent updates to this strategy;

– Performing with the first level safety signal detection and signal evaluation activities (e.g., safety

database and literature review, health authority queries) for Astellas products, and finalizing these

assessments in conjunction with the JSO/GSO and/or other PVSs.

• Support the JSO/GSO, or other PVSs, as applicable, for inspection /audit readiness activities and CAPA
commitments.

• Under the direction and supervision of the JSO/GSO, or other PVSs, provide guidance and support to Medical
Writing vendors in developing key deliverables by actively participating in working sessions to create timely
deliverables, share perspectives, and suggest improvements such as:

– Support the vendor, contribute to risk management activities of assigned products, including

preparation of the Risk Management Plans (RMP) and execution of risk management strategies in

collaboration with internal and external stakeholders.

– Collaborate with the vendor and contribute in the preparation of the relevant signal and risk evaluation

sections of the PSUR and DSUR.

– Perform the creation of JP local periodic reports including J-PSUR, J-DSUR, Re-examination

Application document, etc., and J-RMP.

• Support the drafting of revisions to the RSI section and expected events list for the IB in conjunction with risk

evaluation during DSUR preparation and/or signal evaluations.

• Ensure the accuracy, quality, and timeliness of all assigned responsibilities and tasks

• Assist with data requests, document preparation and/or review of data.

• If requested, support the Drug Safety Assistant with activities such as meeting scheduling, meeting minutes,

and tracking of adherence to deliverables.

（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＞

• Bachelor's degree with related health science background preferred or clinical pharmacy experience strongly

preferred. Candidates lacking the preferred experience or appropriate Bachelor’s degree but with previous

pharma experience may be considered.

• Two years PV experience or associated field (i.e., regulatory, clinical development, medical affairs) or relevant

clinical practice experience is required.

• Understanding of ICH/FDA/PMDA PV related regulations and guidelines affecting drug safety issues.

• Core understanding of safety signaling activities.

• Experience with safety surveillance analysis.

• Must be proficient with technology (Windows, Word, Excel, Outlook, PowerPoint). Proficiency in MS Teams

and SharePoint desired.

• Proficiency in English language, both oral and written, to support working in global environment.

• Ability to communicate and present ideas both orally and in writing.

【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 → 2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 → 2nd 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（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.