Japan Safety Leader - 製薬会社

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-2203-469374

☑Foreign business
☑English language required
☑Japanese language required

Japan Safety Leader

[Company Description]

  • 「世界で評判のいい製薬会社」ランキング上に選ばれる社会的評価の高い会社です

Responsible for managing following major tasks, and advise other colleagues based on rich Pharmacovigilance (PHV) expertise as Senior Staff

  • Monitor the benefit risk profile of assigned portfolio in an ongoing fashion by organizing PVPT and providing evaluation to Safety review Meeting (SRM) and by chairing the local Safety Management Team (SMT).
  • Ensure effective and timely delivery of safety-related documents, such as PHV part of NDA dossier, replies to Health Authority (HA) inquiries, RMP, Proper Use Guide, EPPV report, J-PSUR and emergency letter.
  • Drive strategic preparation for the NDA filing/approval/launch of products in charge by fostering team spirits among PVPT and local SMT
  • Communicate in a timely, transparent and proactive manner with GPV functions about local RMP/Risk Monitoring and Risk Minimization
  • Activities including update of Global Tracking Too


  • At least 5 years of experience in a Pharmacovigilance role
  • Good knowledge of pharmacovigilance relevant regulations
  • High quality writing skills in safety relevant documents
  • Good communication skill with counter parts such as relevant department, regulatory agency and global relevant team
  • Building partnerships and working collaboratively with others to reach common goal
  • Excellent problem solving skills in complex, high quantity and sometimes contradictory information.

[Language Requirement]

  • English Language level: Business level
  • Japanese Language level: Native Level (Equivalent to JLPT N1)
  • Work permission in Japan required

9〜13 million JPY
※Experiences and skills will be considered

Please click "apply" if you are interested in the job.
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Further details about the company and position will be notified at a later date.

Reference: JO-2203-469374
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance