Associate Director (Safety, PV) - Pharmaceutical Company

勤務地 Tokyo, Japan
職種 正社員
給与 ¥11000000.00 - ¥14000000.00 per annum
専門 ライフサイエンス・ヘルスケア・医療機器・製薬,
Sub-specialization 安全性試験 / 安全性管理,
お問合せ Yuichi Matsuda
参照 JO-1911-430015
see Yuichi's jobs

[Company Description]
Global Pharmaceutical Company

[Responsibilities]
By assuring timely case receipt, processing and reporting, updated contracts and agreements and inspection readiness, this function will ensure compliance with PV Regulatory requirements and thereby contribute to the overall the company business goals.

  • Manage the end-to-end processing of adverse event reporting, including initial triage, data entry and e-transmission to regulatory authorities for all company medicinal products
  • Ensure compliance with regulatory reporting requirements for all company medicinal products
  • Support monthly reconciliation of submitted safety information with company M&S, Competent Authorities and partners
  • Maintain and develop SOPs and training within the area of responsibility
  • Ensure administration, maintenance and upgrading of PV database
  • Ensure coordination of development and maintenance activities internally between IT, QA and PV and externally with database software vendor½
  • Ensure that the company's safety database is continuously kept in a validated state
  • Lead, manage and develop direct reports
  • Participate in the Global PV management team
  • Support PV database training of GPV and M&S personnel (data entry + administration)

[Requirements]

  • Life Science degree
  • 5+ years of experience in PV area
  • 2+ years of people management
  • Experience with PV databases and systems admin
  • PM experience and knowledgeable in GDP/G(IT)P
  • Fluency in English and Japanese

[Employment Type]
Full time

[Salary]
11 Million yen ~ 14 Million yen
(Experiences and skills will be considered)

[Location]
Tokyo


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