General Information

Job Advert Title: Senior Manager Affiliate Operations, Pharmacovigilance

Location: Nihonbashi, Tokyo

Division: Pharmacovigilance

Employment Class: Permanent

Description

【Purpose & Scope】

Responsible for the development and maintenance of operational excellence of the Pharmacovigilance (PV) Affiliate Management (AFM) Function and Governance. 

Responsible for day to day interactions with and guidance of the Astellas PV Affiliate Drug Safety Officers (DSOs) to ensure Affiliate local PV systems, processes and procedures are compliant and efficient and in line with global/regional regulatory requirements and Astellas policies and procedures.
At the same time, drives
the global harmonization of processes and procedures.



【Essential Job Responsibilities】

The role is responsible for the development and maintenance of operational excellence of the Pharmacovigilance (PV) Affiliate Management (AFM) Function and Governance. In addition he/she is responsible for day to day interactions with and guidance of the Astellas PV Affiliate Drug Safety Officers (DSOs) to ensure Affiliate local PV systems, processes and procedures are compliant and efficient and in line with global/regional regulatory requirements and Astellas policies and procedures. 

The Sr manager is responsible for (but not limited to) 

- Compliance Oversight 

- PV Inspections and Audits readiness and CAPAs

- Monitoring the Data Quality of the affiliate PV System

- Maintenance of Quality Documents/drives the global harmonization of processes and procedures.

- Training

- Project activities



【Qualifications】

<Required>

・Degree in Health Science, Life Science, Medical Science or equivalent by experience (BS/MSc degree or equivalent.

・Seven (7)+ years experience within PV or equivalent. A technical expert or manager with an in-depth understanding of all aspects of pharmacovigilance and related disciplines and a strong industry perspective.

・Excellent communication and influencing skills to deal with cultural sensitivities and to influence and motivate others. Demonstrate tactfulness, diplomacy and a global mindset. 

・Service orientated and pro-active problem solving attitude.

・Good organizational skills, logical in thought and detail focused.

・Demonstrate proactive innovative, developing skills and continuously strives for improvement opportunities

・Awareness of local industry code(s) of practice.

・Excellent verbal and written English language skills.

・Ability to work independently.

・Good understanding of good documentation practices.

・Ability to work with (company) required IT systems.

・Willingness to travel up to 50%.


<Preferred>

・Project management experience 

・Fluency in an additional language is preferred



【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50,000~100,000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】

年一回

Once a year



【賞与 / Bonus】

年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)、8:45~16:00(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

8:45~17:45(Mon~Thu)、8:45~16:00(Fri)

Discretionary Work System



【休日 / Holidays】

完全週休2日制、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



【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。



"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."