ファーマコビジランス (SABR) - バイオ医薬品メーカー

勤務地 東京都
雇用形態 正社員
給与 ¥9000000.00 - ¥13000000.00 (年収)
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
職種 安全性試験 / 安全性管理,
お問合せ Yoshiko Kumakura
JOB ID JO-2111-465363

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

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[Position] ファーマコビジランス(SABR)
[Location] 東京都
[Salary] 9〜13 million JPY ※Experiences and skills will be considered
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[Company Description]
外資系バイオ医薬品メーカー

[Responsibilities]
You will perform the following activities with minimum supervision:

  • All of the pharmacovigilance activities both for post-marketing products and investigational products.
  • Collaboration with global PV, medical safety and other relevant teams to secure all of the PV activities in Japan fulfil the regulatory requirements.
  • Collaboration with cross functional team members to achieve CTN, IND and NDA etc. in Japan and contribute to the new products approval.
  • Support safety supervisor to secure pharmacovigilance QMS, and maintain the BCP

What You'll Do:

  • Safety information handling for post-marketing and investigational products
  • Serves as subject matter expert to take safety measure for assigned products (Package insert revision, IB, RMP etc.)
  • GVP activities (PV training, Audit, SOPs creation and maintenance, documents archiving etc.)
  • Vendor and partners management
  • Contribute to the IND and NDA etc.
  • Collaboration with global team and cross functional teams for all of the PV activities

[Requirements]

  • B.S. degree required, science degree preferred, but not limited to.
  • Minimum six years experiences of pharmacovigilance in the pharmaceutical industry.
  • Experience with interacting with third parties (e.g., contract service providers) .
  • Direct experience in GVP compliant quality systems.
  • Experience to use ARIS database


Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Reference: JO-2111-465363
Seniority Level: Mid-Senior level
Job Function: Health Care Provider