Johnson & Johnson Careers
【Janssen 】PV Associate, JSS Safety Risk Management Dept.
Requisition ID: 1805636784W
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.
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.
・Risk Management Planの作成及び実行（あることが望ましい）
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.
Janssen Pharmaceutical K.K. (7195)
Drug & Product Safety Science