General Information

Job Advert Title: Risk Management Director

Location: Nihonbashi, Tokyo

Division: Pharmacovigilance

Employment Class: Permanent

Description

【Purpose & Scope】
The Risk Management Director is responsible for the development of risk management activities and strategic planning and is a member of the GD Product sub- teams. It is the responsibility of the Risk Management Director to delineate (define, plan) risk management strategies that are aimed at achieving optimum benefit-risk for products throughout the lifecycle of the drug. The individual will use strong leadership, communication, and risk management expertise to successfully advise resources and ensure effective collaboration across GPV functions and sites.
The Risk Management Director will partner with Medical Safety, Epidemiology and other GPV functions to optimize the ability for teams to provide RM deliverables in the agreed upon timeframe. In addition to working with GPV stakeholders, the Risk Management Director will partner with the Medical Sciences, Statistics, Regulatory, Legal, Pre-Clinical disciplines, European Safety Office and other key stakeholders to effectively plan risk management strategies that enhance Therapeutic Area Strategy and project/product life-cycle management.


【Essential Job Responsibilities】
・Leads the development of policy for project/product risk management strategy (D-Risk Management Plan) and internal and regulatory action plans for real and theoretical safety risks in partnership with the project/product team, and advises product teams to ensure clear and balanced communication to senior management.
・Advises product teams in a manner to optimize the implementation of risk management strategies for specific risk assessment activities and documents, coordinating and/or authoring documents as appropriate, providing project teams/senior management with a comprehensive recommendation on risk management strategy.
・Organizes and provides administrative support to the appropriate governance committees by ensuring that routine updates are provided.
・Advises product teams for development of Investigator Brochure activities where appropriate (i.e.“Advice to Investigators” Section).
・Oversees the policy that is developed for teams that will be responsible for authoring, updating, and maintains the Risk Management Plan (RMP, EU-RMP, REMS), ensuring compliance with current local regulatory requirements. The RML advises teams to ensure that post marketing risk management activities are aligned with the Risk Management Plan.
・Advises teams to lead development of peri- and post-approval safety commitments during the endgame and approval phases, and may assist in negotiating these commitments with regulators; coordinates post-approval safety commitments.
・Assists teams with communication and knowledge transfer across project/product teams, Therapeutic Areas, and GPV regarding risk management positions, policies and strategies.
・Creates and fosters an environment of partnership and collaboration between GPV and the project/product team. Develops and sustains constructive relationships with preclinical disciplines, Medical Affairs and other APGD teams.
・Supports the Global RM Head with designing the risk management function Global PV, timely implementation, and evaluation of the function.
・Advises teams to ensure risk management awareness and communication at investigator meetings, as appropriate.


【Organizational Context】
This position with be located within the Risk Management function of GPV and will report directly to the Head, Risk Management.


【Qualifications/ Required】
・Advanced health related sciences degree (PhD/PharmD) or MD; or equivalent.
・At least 5-10 years pharmaceutical/health related industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development, with at least 3-4 years of direct experience in risk management (in a global setting preferred).
・Key leadership responsibilities in previous role(s) preferred.
・Global responsibilities in previous role(s) preferred.
・Strategic thinking, Organizational, Leadership. Results-oriented performance. Team player.
・Excellent knowledge of ICH, US & EU regulations and requirements for pharmacovigilance
(experience with world-wide safety reporting regulations and guidelines required).
・Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally.
・Proven ability to effectively lead cross-functional teams with respect to risk management activities and to influence where direct reporting line relationships do not exist.

Technical Competencies
Understands and can develop risk management strategy, both in clinical development and in post-marketing setting. Recognized as a credible leader in the area of Risk Management; Can handle more than one complex project simultaneously, prioritizing well and recognizing key issues; Effectively identifies issues that need to be brought to management (also bringing proposed solutions) versus issues to be handled independently. Can work with minimal supervision; Runs effective meetings, including all colleagues’ diverse opinions and bringing group to consensus. Next steps and actions are clear; Understands aggregate safety data and signal assessment; thorough understanding of Risk Management internal and external environment,
including applicable regulations and guidance; Comprehensive knowledge of drug development process.

Behavioral Competencies
Influences effectively across lines. Develops matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues’ areas of expertise and utilizes them effectively to achieve team objectives; Champions high quality deliverables, innovation, and appropriate risk-taking; Ability to understand the sensitivities within the Astellas environment.



【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

住宅手当、通勤手当 等

Housing allowance, Commutation allowance, etc.



【勤務時間 / Working Hours

 管理監督者 8:4517:45(月~木)、8:4516:00(金)

 Managers and Supervisors 8:4517:45MonThu)、8:4516:00Fri



【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。


"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."