Job Advert Title: RAPV Affiliates Operations Professional
Location: Nihonbashi,Tokyo
Division: Regulatory Affairs and Pharmacovigilance
Employment Class: Permanent
Description
【募集の背景 / Purpose & Scope】
Summarize the primary purpose of the position in 1-3 sentences. Intent is to capture the work this position does and is accountable for and why the role exists as a unique position. Not intended to be a summary of all duties.
The purpose of this role is to drive a Culture of Quality within the Regulatory Pharmacovigilance (RAPV) Quality and Compliance function as well as with the Astellas PV Affiliate teams.
【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
Quality, Oversight and Compliance Management
・Support compliance activities in alignment with regulatory requirements and Astellas procedures
-Maintain Astellas’ reputation and protect patient safety by mitigation & escalation of identified issues/risks and take corrective and/or preventive actions, as required.
-Support RAPV Q&C colleagues and/or other stakeholders for process improvements resulting from compliance failures.
・Ensure oversight over compliance-relevant aspects (e.g., ICSR timelines/quality, training, CAPAs, and updates of procedures at the local PV Affiliate level).
-Perform root case analysis (RCA) pertaining to ICSRs submitted late to Health Authorities (HA), CROs and Business Partners.
・Support/provide input to the PSMF, as requested.
・Support RAPV colleagues and PV Affiliate staff, before, during and after, HQ Inspections, local Affiliate Audits, license partners audits and local HA PV inspections.
-Represent RAPV Q&C in Audits and Health Authority Inspections (on-site and/or co-located), as required.
-Support Audit and Inspection-readiness activities.
-Support the development of CAPAs (global/regional/local) from initiation to completion.
・Work with RAPV Q&C, (non) RAPV colleagues and Affiliate staff to identify actions to improve quality, compliance, and efficiency for the local Affiliates.
Project(s)
・Support the initiation, execution, and completion of RAPV projects under supervision of a more senior colleague and/or manager.
・Ensure that project related processes, procedures and documents are in an up-to-date state and archived (“Audit/Inspection ready”).
・Contribute to and collaborate with RAPV and QA colleagues in quality improvement projects.
Procedural Documents
・Support the development, review and maintenance of RAPV Q&C/RAPV Affiliate PDs and drive consistency between PDs.
Relationship Management
・Act as a Point of Contact for and work with stakeholders within RAPV Q&C, RAPV HQ functions, RAPV Affiliate teams, EU QPPV and non-RAPV functions for topics related to quality and compliance that impact RAPV activities.
・Support RAPV and non-RAPV functions in due diligence activities of potential new product acquisitions/divestments/local country licensing agreements, if applicable.
・Support Business Partner Management (BPM), Procurement or other functions for the maintenance of contractual arrangements (e.g., Master Service Agreements (MSA) or PV Agreements (PVAs)).
・Attend regular team meetings, teleconferences, and/or project team meetings with globally located colleagues.
・Maintain timely and effective communications among cross-functional PV team members, vendors, and business partners.
Training
・Provide training to RAPV and non-RAPV colleagues, vendors, and other 3rd parties, as required.
（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】
・This position is based in Japan.
・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＞
•Degree in Health Science, Life Science, Medical Science or equivalent by experience (BS/MSc degree or equivalent.
•At least two (2) years’ experience within PV or equivalent.
•Basic understanding of PV aspects and related disciplines.
•Good communication skills, ability to deal with cultural sensitivities and to motivate others. Demonstrate tactfulness, diplomacy and a global mindset.
•Ability to work independently with minimal supervision
•Service oriented attitude and problem-solving attitude.
•Good organizational skills, logical in thought and detail focused
•Identify and supports improvement opportunities.
•Excellent verbal and written English language skills.
•Solid understanding of good documentation practices.
•Ability to work with (company) required IT systems; Microsoft office (excel, word, PowerPoint, TEAMS)
•Willingness to travel.
＜歓迎 / Preferred＞
•Fluency in an additional language
【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）
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."