基本情報

求人名 Associate Manager, PV COPE (Compliance, Oversight & Process Excellence)

勤務地 Nihonbashi, Tokyo

事業部 ファーマコヴィジランス

雇用形態 正社員

仕事内容

【Purpose & Scope】
The Associate Manager, PV COPE works independently or with minimal supervision, and is responsible for implementing operational plans in own region, in support of global Audit and Inspection Readiness and Process Improvement and/or quality oversight, compliance metrics & PI/KPI management and/or the management and/or maintenance of controlled safety documents (e.g., SOP, WPD); collaborating with relevant PV and non-PV Astellas partners (e.g., Global Clinical and Research Quality Assurance, Global Regulatory Affairs), globally.
Participates in projects related to Audit and Inspection management and Process Improvement, and/or Controlled Document management, and/or Quality oversight and/or Compliance management, representing PV COPE and taking ownership for specific tasks and deliverables, in order to ensure oversight over, as well as compliance with, all applicable worldwide pharmacovigilance regulations and internal and external PIs/KPIs.
Reports to the Senior Director, Director, Associate Director, Senior Manager PVCOPE. Is a member of the PV-COPE team and contributes to the development, implementation and successful execution of the PV mission, objectives and 3-5 year strategic plan.


【Essential Job Responsibilities】
Compliance & Data Analytics
• Implement and maintain tools and processes, to identify and monitor compliance and quality metrics for the entire pharmacovigilance department, PV license partners and vendors for outsourced PV activities.
• Ensure continuous monitoring on compliance, timeliness and quality metrics, including detected patterns and trends, in close collaboration with internal (other functions within Global PV and the JP- and EU-QPPVs) and external stakeholders (Regulatory Affairs, Quality Assurance, license partners);
• Report on metrics of (outsourced) PV processes, and process related key performance indicators; provide feedback on performance to functional groups on request or proactively in case on non-conformances.

Inspection / Audit Readiness & Response
• Support PV including local affiliate staff, before, during and after, internal audits and external Health Authority inspections, local affiliate audits, license partners audits and local PV inspections in own region, including onsite support if required (e.g. coordinating pre-audit/inspection requests, provide inspection readiness training etc.).
• Act as a member of inspection operational team taking ownership for specific tasks or deliverables and/ or as a member of the back-office or as scribe during regulatory inspections.
• Coordinate the preparation of audit/inspection responses and coordinates the preparation of PV Corrective and preventive action plans and deviations; provide guidance and support to the PV functions on the administrative process and evidence collection.
• Monitor compliance with timelines for inspection/audit responses, internal commitments and effectiveness checks; escalate risks for delays and need for extensions to PV COPE management as required.
• Implement best practices in audit / inspections management in close collaborations with regional Quality Assurance functions.
• Support the responses for risk assessment questionnaires from both regulatory authorities as well as business partners
• Support content for History of inspection section in addendum for Clinical overview (ACO)

Process Improvement
• Conduct trend analysis of aggregated inspection/audit findings to serve continuous improvements, and to avoid repetitive findings.
• Participate as project team member or subject matter expert, in projects to improve regulatory compliance and PV processes, systems or tools, in close collaboration with functional stakeholders and other PV-COPE team members.
• Support 24 hour availability testing for EU-QPPV

Standards & Quality Documents
• Support the maintenance of PV controlled safety documents (e.g., SOP, WPD) and controlled documents structure, including regional translations, as required; maintains the PV controlled safety document road map.
• Provide support for PV staff in own region, for writing/ implementing changes to quality documents, ensuring compliance with periodic review of documents, and compliance with applicable SOP writing procedures, templates and style guides.
• Collect and coordinate requests for improvement of PV business processes within the global team, supporting the implementation of new legislation into quality documents.
• Assess new or revised SOPs or other applicable quality documents, whether arising within the affiliates or other Astellas functions, or global documents linking in to the Pharmacovigilance system, for impact on PV.
• Facilitate the review and approval process of cross-functional SOPs, and WPDs that involves PV work- related responsibilities. Working closely with colleagues in other departments and within the Global quality network to ensure these processes are reviewed and approved.
•Assist with ensuring ready availability/accessibility and understanding of controlled safety documents by all staff.

Data Governance
• Support Data Governance function through use of processes and tools that will deliver high quality data for decision making from both internal and external sources.
•Maintain awareness of functional Data Governance activities with potential downstream implications, align ongoing initiatives through performing impact assessments, raising issues and identifying and coordinating solutions.


【Organizational Context】
• Reports to the Senior Director, Director, Associate Director, Senior Manager, PV COPE. Peers include PV COPE Associates and Associate Managers and other PV Operations team members.
• The Associate Manager, PV COPE interfaces directly with internal PV and non-PV subject matter experts, including the PV responsible staff in the affiliates, and other Astellas partners, including Clinical and Research Quality Assurance, Global Regulatory Affairs, and Clinical Development Operations, and external CRO representatives or business partners.


【Required】
• Minimum BA/BS
• Minimum of 4 years in pharmaceutical, biotechnology, or related industry
• Minimum 2 years experience in Pharmacovigilance (e.g. in case processing), Regulatory affairs or Safety Quality Assurance, preferably experience in support of the safety quality systems
• Understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations, experience and understanding of Process Management, Standards, Training & IT function as they apply throughout the entire pharmaceutical compound/product life cycle
• Good understanding of PV and Clinical Research processes, and other processes making up the PV system, including the interfaces between these processes
• Very good understanding of PV, data management and adverse event reporting and processing
• Excellent oral and written communication skills, ability to interact with all levels of personnel
• Must be able to communicate in English (active and passive), other languages considered an asset
• Computer literacy (including Microsoft Office, Access and Project)



【勤務地 / Location

東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo



【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50,000100,000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

年一回

Once a year



【賞与 / Bonus

2回(7月、12月)

Twice a year (July, December)



【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)、8:4516:00(金)、企画業務型 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

8:45~17:45MonThu)、8:4516:00Fri

Discretionary Work System



【休日 / Holidays

完全週休2日制、祝日、51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



【お問い合わせ / Contact

アステラス製薬株式会社 採用担当 / Japan Recruiting team, Astellas Pharma Inc.

astellas.recruit@jp.astellas.com

※本職種についてのご質問は、上記までお問い合わせください。



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