募集要項
- 募集背景
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【Basic purpose of the job】
- Based on sound medical knowledge, this role defines the local Patient Safety & Pharmacovigilance (PSPV) strategy not aonly for the delegated asset (AT) but also other products as needed and ensures the consistent implementation of the BI risk mitigation strategy to safeguard patients and / or clinical trial subjects by providing benefit/risk (B/R) expertise to the cross-functional teams based on the framework provided by Global PSPV .
- Together with the LPSL, the local Patient Safety Physician (PSP) ensures by contributing to the local PSPV strategy and by responsibly taking care of delegated parts of the local PSPV system to establish and maintain a high-quality local PSPV system which is compliant with external regulations and internal processes.
- 仕事内容
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【Accountabilities】
As an expert of benefit/risk (B/R) profile, which are assessed by global BR team and aligned among global and local, engage to take safety assurance measures such as preparation of J-RMP, proper use of drugs and closely work with evidence/asset team by providing B/R knowledge and work with global team by inputting local needs/insight.
-Lead to prepare local Risk management Plans in response to Japanese specific requirements and content in liaison with GPV functions.
-Implementation and progress of global risk minimization measures, lead to prepare local RMP development and implementation not only for the delegated asset (AT) but also other products as needed.
-Perform local safety data monitoring not only for the delegated asset (AT) but also other products as needed.
-Promote implementation of safety assurance measure such as proper use of drug, including preparation of guidelines for them in collaboration with stakeholders (e.g.LRA, legal &complaince)
-Perform Medical Quality Review of all fatal / life-threatening cases as needed and defines appropriate follow-up measures. Complete ‘fatal case investigation’ report as needed.
Contribute to the PSPV Culture, Local PSPV Strategy & the establishment and maintenance of a high-quality local PSPV system, Review controlled documents (e.g. PV Working Instruction, PV Repository, applicable sections in PSMF annexes, local SOPs, etc.) also contribute to Japan initiatives to promote Patient Safety & Pharmacovigilance concepts and conduct PV trainings, where the training needs were identified, for internal and external customers.
To be ready for PV audits and PV/GPSP/GCP inspections. inspection and support to management of non-compliance.
Proactively cooperation with Global PSPV on any upcoming new regulations or Our processes to assess the local impact and their implementation within the team.
and ohters
- 応募資格
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- 必須
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[Job Expertise]
・1+years’ experience at Experience at pharmaceutical industry at medicine department
・Experience in the field of clinical development is highly preferable
[Minimum Education/Degree Requirements]
・Medical doctor (Experience as clinician)
[Required Capabilities (Skills, Experience, Competencies)]
Knowledge and experience ・Substantial knowledge about local GVP/GPSP regulation and global GVP regulation.
・Knowledge and experience of preparation of periodic report/RMP/EPPV
・Knowledge and experience of performing signal monitoring
・Knowledge and experience of PJ management
・Experience on industry activities (e.g. participating working group across companies) (preferable)
・Excellent command of English language (TOEIC score more than 785)
Skill and Competencies
・Proactive and assertive attitude to establish team and networking
・Problem solving skill and crisis-management skills
・Analytical skills on industrial trend.
・Conceptual and strategic thinking
・Project management and decision-making skills
・Ability to mentor, coach and train others
・Proactive and assertive attitude with customer service orientation
・Excellent communication and presentation skills
Language skills:
・Japanese: Native level
・English: Fluent
Required English speaking CEFR level : B2
- 歓迎
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・Excellent knowledge of applicable global, regional and local PV regulations, Our processes and relevant GxP requirements.
・Be compliant and acts within ethics at all times.
- 雇用形態
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Full－time employee ; Trial period: 3 months
正社員 ※試用期間：3カ月
- ポジション・役割
- Non-Line Manager or Group Manager/Patient Safety & Pharmacovigilance Department
- 勤務地
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Work location: Head office: Shinagawa－ku, Tokyo
本社（東京都品川区）
- 勤務時間
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Working hours: 8:45－17:20 （including 45 min break） for 7 hrs and 50 min, with flexible working hours depending on work conditions.
＊Flexible working hours （no core time）
＊Telework available (Hybrid work)
8時45分～17時20分 の7時間50分 (休憩45分) が基本で、業務状況に応じてフレキシブルに勤務可能。
※フレックスタイム制（コアタイムなし）
※テレワークがメインとなります。
- 年収・給与
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Expected annual salary （guideline）: 8 million to 16 million yen
想定年俸（目安）：800万円～1900万円程度
※年齢、経験、現年収、potential等を考慮して決定。
※想定年収は、月給＋業績賞与（年1回：4月支払い）の合計額。
※残業手当、その他手当は別途支払い（スタッフの場合）
(上記および待遇・福利厚生の一部は今後変更される場合があります。）
- 待遇・福利厚生
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Benefits and Employee Benefits:
All types of social insurance （health insurance, pension insurance, employment insurance, worker's accident insurance）
Childcare support, medical expenses subsidies （including spouses and dependents）, and rental subsidies., etc
各種社会保険（健康保険・厚生年金・雇用保険・労災保険）完備、出産一時金、退職金制度、借上社宅制度（弊社規定に依る）、福利厚生倶楽部（日本リロケーション）法人会員、カジュアルフライデー制度（内勤）、財形貯蓄、福利厚生倶楽部法人会員、共済会、持家ローン利子補給制度等
・育児支援、医療費補助（配偶者、扶養家族も対象）や賃貸家賃補助（引越し費用、下見交通費を含む）なども含め、福利厚生は大変充実しています。
・多くの職種においてコアタイムのない完全フレックスタイム制度や、オフィス以外の場所からでも勤務できるテレワークを推進し、柔軟かつ効率的な働き方を志向しています。
※社内全面禁煙
- 休日休暇
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Holidays: 2 days off per week, 120＋ days off per year
完全週休2日制、年末年始、祝日、創立記念日（7/1）、セレクト休日、祝日が土曜に重なった場合は翌労働日が休日、フレックス休暇、リフレッシュ休暇、慶弔休暇
＊年間休日数120日以上
＊有給休暇：初年度は4～13日（入社月により変動）
- 選考プロセス
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Document screening, interview (2 times), aptitude test
Phone/web interviews available
書類選考、面接(2回）、適性検査
※一次面接はWEB、電話での対応も可能です。
※二次（最終）面接は神戸または東京本社で実施、交通費等は実費を支給します（平常時）。
付記：
【職業安定法施行規則改正（令和６年４月１日施行）に伴う明示】
１ 従事すべき業務の変更の範囲：会社内での全ての業務を命じることがある。
２ 就業の場所の変更の範囲：当社の全事業場および出向先・派遣先としての他の会社・法人・団体。
- キャリアパス・評価制度
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・非上場企業で経営は安定し、福利厚生も大変充実しています。
・人材教育と可能性を重視し、キャリアパスとしてのトレーニングシステムが充実しているので、新卒者からシニアまでの広い年齢層の仲間と共に、キャリアパスを磨くには好適な環境です。
・英語等で交流する機会は多く、スキルアップにはとても良い環境にあります。また英語学習補助システムがあります。
