1. 転職サイト ビズリーチ
  2.  > 
  3. 求人検索
  4.  > Senior manager
  5.  >  Risk management strategy

転職・求人情報の詳細をご覧になる場合は会員登録(無料) が必要です

新規会員登録(無料)

Senior manager, Risk management strategy

年収:1000万 ~ 1300万

ヘッドハンター案件

部署・役職名 Senior manager, Risk management strategy
職種
業種
勤務地
仕事内容 Functional Area Description
The WWPS-J group is responsible for ensuring the safety of our medicines by conducting the following:
・pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring,
・safety reporting, contribution to benefit-risk assessment,
・risk management planning and strategy, and
・execution of post-marketing commitments
・ensuring compliance with global regulatory requirements.

Position Summary
This role provides leadership as a senior level safety scientist
・To lead Strategic Safety Management in BMSKK
・To develop RMS organization to provide maximum outcome effectively with embody our mission, vision and value
・To lead the optimal operations with strategic planning in order to realize risk minimalization by planning, operating, and promoting of activities
・To ensure benefit-risk balance across the product lifecycle for the products by executing appropriate safety measures.
・To ensure the safety of the subject in clinical studies.
・To contribute NDA activities from the safety perspective for the patients’ early and appropriate access to the products.
・To ensure excellent regulatory compliance and credibility.

Position Responsibilities
1.Risk management
 Conducts safety review and potential signal detection and proposes the safety measures and safety communications for the products
 Prepares and submits the initial and updated J-RMPs
 Drafts and updates the precautions in J-PI
 Reviews or prepares the safety part of the documents of clinical studies (Protocol, ICF, IB, CSR, etc.)
 Prepares the response to the inquiries from PMDA for NDA and post-marketing phase
 Prepares and provides the materials for proper use (Proper use guide, Patient leaflet, Interim/ Final report of EPPV, etc.)
 Plans and implements EPPV.
 Plans and implements safety assurance measures

2.Safety reports
 Prepares and submits periodic reports (J-DSUR and Non-serious unexpected adverse reactions report) to PMDA. Drafts the part of safety part of J-PSUR.
 Prepares and submits EPPV reports to PMDA.
 Prepares and submits research reports and safety measure reports to PMDA.
 Prepares the applications for re-examination and re-evaluation

3. Cross-functional collaboration
 Supports the clinical study team from safety perspective
 Collaborates with relevant departments to ensure safety measures
 Trains staff on product safety profile and risk minimization measures.
 Contributes to ensure the benefit-risk profiles.

4. Safety control activities/ compliance
 Ensures the awareness of the changes in regulations and evaluates the impact on local processes.
 Ensures the appropriate safety vigilance procedure and in interactions with other department and Global Drug Safety and Risk Management (GDSRM).

5. Development of organizational culture
 Supports of culture cultivation such as our mission, vision and value
 Leads team members for ensuring the implementation of company policies, SOPs, processes, etc

6. Organizational management
 Coachs and mentors to develop RMS members
 Manages budget and outsources tasks to slim down
応募資格

【必須(MUST)】

Degree Requirements
1.Minimum of B.S. or the equivalent education in life science
2.Fluent in Japanese and English with ability to work in global context

Experience Requirements

Required experience
1.Ten (10) years pharmaceutical/biotechnology industry experience
2.Ten (10) years drug safety experience
3.Clinical experience preferred
4.Management experience preferred

Required knowledge
・Pharmaceutical and Science background
・Mastery of global / local Pharmacovigilance/safety regulatory requirement (Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations, GCP, GVP, GPSP, etc.)
・Proficiency in safety processing (GVP-SOP, Global SOP, etc.)

Key Competency Requirements
1.Scientific/Technical thinking
2.Group Leadership
3.Communication/ cross-functional collaboration skill
4.Presentation skills

Why You Should Apply

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

We recognize the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

私たちは世界中で、深刻な病気の患者さんの生活に影響を与えることに情熱を注いでいます。包摂的な文化の中で個々の才能と多様な視点を適用する力を持ち、情熱、イノベーション、アージェンシー、責任、インクルージョン、インテグリティという共有の価値観が、社員一人ひとりの最高の可能性を引き出しています。

私たちは、職場環境におけるバランスと柔軟性の重要性を認識しています。当社では、従業員が仕事でも私生活でも目標を達成するためのリソースを従業員に提供するために、競争力のあるさまざまなの利益、サービス、プログラムを提供しています。
リモートワーク

「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります
受動喫煙対策

その他

「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください
更新日 2022/06/30
求人番号 2256501

採用企業情報

この求人の取り扱い担当者

この求人に含まれるキーワード

転職・求人情報の詳細をご覧になる場合は会員登録(無料) が必要です

メールアドレス ※ メールアドレスは公開されません
新規会員登録(無料)

新規会員登録(無料)ボタンをクリックすると個人情報の取り扱い、及び、利用規約に同意したものと見なされます

転職が決まりご報告いただいた方にはお祝いを用意しております。

ページ先頭へ