【Janssen】Japan R&D, Safety Risk Management Dept. Risk Management Leader/ PV Associate (Senior Specialsit)

仕事内容


POSITION SUMMARY:

<JRML for Early Phase and/or Established Products>

 Lead and facilitate J-SMT meeting in collaboration with JPKK’s key stakeholders including JCoT (Japan Compond Team) members in responsible products/compounds.

 Take full accountability to prepare prepare and maintain Strategic Safety Monitaring Plan in responsible products/compounds.

<PvA for Late Phase including NDA and/or sNDA Products>

 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.

 

PRINCIPAL RESPONSIBILITIES:

<JRML for Early Phase and/or Established Product >

 Lead and facilitate J-SMT meeting in collaboration with JPKK’s key stakeholders including JCoT members in responsible products/compounds.

 Take full accountability to prepare and maintain Strategic Safety Monitaring Plan in responsible products/compounds.

 Take full accountability to aggregate reporting such as J-DSUR and Non-serious unlisted periodic report including reports for medical devices.

 Lead and manage PvA and PMSO in responsible products/compounds.

 As an extended member of Global Safety Management Team(G-SMT), liaise with  G-SMT of responsible products/compounds.

 Join JCoT, NPI and other related committee with license partner companies as a representative of J-SMT in responsible products/compounds.

 Liaise with all other internal and external key stakeholders of responsible products/compounds.

 Plan and monitor budgets and controls expenditures for responsible products/compounds in collaboration with Group manager/ Director and Strategic Risk Communication Group.

 
< PvA for Late Phase including NDA and/or sNDA Products >

 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, Re-examination 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 products/compounds.

 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 products/compounds.

 Plan and monitor budgets and controls expenditures for responsible products/compounds in collaboration with JRML and Strategic Risk Communication Group.

 

REPORTING RELATIONSHIPS: 

Report to Group Manager of Risk Management Group, Safety Risk Management Dept., directly.

 


資格

EDUCATION, EXPERIENCE & SKILL REQUIREMENTS:

- A BA degree in a biological or medically related field is preferred.

- 8-year or more experiences in pharmaceutical industries are generally recommended.

 - Strong leadership including decision making, management, negotiation, and stakeholder management and communication skills necessary.

 - Ability/competency to show contentious proposals to responsible teams and groups including JCoT.

 - English communication skill (TOEIC 700 point and above), verbal, writing, presenting and facilitating.

 - Scientific & medical knowledge including medical writing skill and local regulations, GVP and GPSP.



プライマリ場所
日本-東京都-千代田区-
組織
Janssen Pharmaceutical K.K. (7195)
ジョブ
Drug & Product Safety Science
Requisition ID
1905783239W