Johnson & Johnson Careers

【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