Johnson & Johnson Careers
【Janssen】 R&D Japan JSS, Safety Risk Management Dept. PV Associate (Staff)
Requisition ID: 1905766563W
Take full responsibility to prepare Japan Risk management Plan (J-RMP) and implement all activities related to risk management under GVP and GPSP in responsible products/compounds
Take full responsibility to create, implement and verify J-RMP including all risk minimization activities for EPPV, risk communication activities and aggregate reporting such as J-DSUR, J-PSUR, Periodic Infection Report and Non-serious unlisted periodic report including reports for medical devices of responsible products/compounds.
・Take full responsibility to prepare and assess a summary of aggregate reports, revision of package inserts, Reexamination dossier, GPSP compliance inspection, Early Post-marketing Phase Vigilance, responses to regulatory inquiries, and others.
・Collaborate with members of JRML and PMSO for above mentioned activities in responsible
・Take a role as a core J-SMT member in collaboration with JPKK’s key stakeholders including JCoT members in responsible products/compounds.
・In a way that supports JRML, liaise with all other internal and external key stakeholders of responsible products/compounds..
・Join related committee including partner companies as a representative of J-SMT of responsible
・Plan and monitor budgets and controls expenditures for responsible products/compounds in collaboration with JRML and Strategic Risk Communication Group.
・5-year or more experiences in pharmaceutical industries are generally recommended.
・Scientific & medical knowledge including medical writing skill and local regulations, GVP and GPSP.
・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.
・A BA degree in a biological or medically related field is preferred
Janssen Pharmaceutical K.K. (7195)
Drug & Product Safety Science