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【Janssen 】PV Associate, JSS Safety Risk Management Dept.
Chiyoda, Japan
Drug & Product Safety Science
Job Description
Requisition ID: 1805636784W
＜職務内容＞
・Risk Management Planの作成及び実行
・DSUR、J-PSUR、未知非重篤定期報告等、各種集積報告作成
・安全性審議委員会の運営
・新医薬品の承認申請に関連する業務（RMP案作成，照会事項回答作成，等）
・再審査申請に関連する業務（再審査申請資料作成，照会事項回答作成，等）
POSITION SUMMARY:
Full responsible for the creation, implementation and verifying Japanese risk management plan within responsible products/compounds.
Responsible for preparing and assessment a summary of aggregate reports, revision of package inserts procedures for reexamination application, early post-marketing surveillance, responses to regulatory inquiries, and others within responsible products/compounds.
PRINCIPAL RESPONSIBILITIES:
Take full responsibility to create, implement and verify J-RMP including all risk minimization activities including EPPV, risk communication activities and aggregate reporting such as J-DSUR, J-PSUR, Periodic Infection Report and Unlisted non-serious aggregate ADR report, within responsible products/compounds.
Prepare and assess a summary of aggregate reports, revision of package inserts, procedures for reexamination application, early post-marketing surveillance, responses to regulatory inquiries, and others.
Collaborate with members of JRML and PMS-Operation for above mentioned activities within responsible products/compounds area.
Take a core role in J-SMT collaborated with JPKK’s key stakeholders including JCoT members, Global Medical Safety and Global Safety Management team within responsible products/compounds.
Join related committee including partner companies as a representative for risk management team of responsible products/compounds.
Monitors budgets and controls expenditures for responsible products/compounds, collaborated with JRML and Strategic Risk Communication Group.
Qualifications
＜職務経験＞
・5年以上の医薬品業界勤務経験
・Risk Management Planの作成及び実行（あることが望ましい）
・DSUR、J-PSUR、未知非重篤定期報告等、各種集積報告作成（あることが望ましい）
＜必要とする能力・スキル＞
・医学的知識，薬学的知識
・薬事法、GVP等の規制関連業務経験
・判断力、プロジェクトマネジメント、ネゴシエーション、ステークホルダーマネジメント、コミュニケーションスキルがあり、課題に対して解決案を提案できる強力なリーダーシップ
＜資格／免許＞
・ビジネスレベルの英語スキル（会話、ライティング、読解、ファシリテーション、プレゼンテーション）、TOEIC600点以上が目安
EDUCATION, EXPERIENCE & SKILL REQUIREMENTS:
A BA degree in a biological or medically related field is preferred.
5-year or more experiences in pharmaceutical industries are generally recommended.
Must have strong leadership including decision making, management, negotiation, stakeholder management and communication skills necessary.
Ability/competency to show contentious proposals to responsible teams and groups.
English communication skill (TOEIC 600 point and above), verbal, writing, presenting and facilitating.
Scientific & medical knowledge including local regulations, GVP & GPSP.
Primary Location
Japan-Tokyo-To-Chiyoda
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Drug & Product Safety Science
Requisition ID
1805636784W