Pharmacovigilance Associate - 製薬会社

Contact: Eureka Teramura
Reference: JO-2009-448214

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
外資系製薬会社

  • 世界100ヶ国以上で事業を展開する大企業
  • 神経、がん、免疫、感染症、循環器などの領域に重点を置いています

[Responsibilities]
■JOB SUMMARY:
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, 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 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.

[Requirements]

  • 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

[Employment Type]
Full time

[Salary]
6M-14M
※Experiences and skills will be considered

[Location]
Tokyo


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