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【Janssen】 R&D Japan, Pharmacovigilance Associate

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Job Description


Janssen Japan K.K. is recruiting for a Pharmacovigilance Associate (PvA), located in Tokyo, Japan.

  • 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.

Key Responsibilities:

  • 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 Japan Risk Management Leader (JRML) and Post-Marketing Surveillance Operation (PMSO) for above mentioned activities in responsible products/compounds.
  • Take a role as a core Japan Safety Management Team (J-SMT) member in collaboration with JPKK’s key stakeholders including Japan Compound Team (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.

Qualifications
Education:
  • A BA degree in a biological or medically related field is preferred.

Experience and Skills:

Required:
  • 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.
  • Scientific & medical knowledge including medical writing skill and local regulations, GVP and GPSP.
Preferred:
  • 5-year or more experiences in pharmaceutical industries are generally recommended.
Other:
  • English communication skill (TOEIC 600 point and above), verbal, writing, presenting and facilitating.


Primary Location
Japan-Tokyo-To-Chiyoda-
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
R&D
Requisition ID
1905787393W