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Area Safety Lead (PV 약사 채용)

職務分類:
掲載日:
終了日:
ID:
2507036126W

この仕事を共有する:

Kenvueは現在、以下求人を募集しております。

Area Safety Lead (PV 약사 채용)

私たちがしていること

私たちKenvueは、日々のケアが持つ驚くべき力を信じています。100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID®など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。 

Who We Are

私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えたKenvuerであることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。 

Role reports to:

Area Safety Lead, South Korea, HK &TW

場所:

Asia Pacific, South Korea, Seoul, Seoul

勤務地:

ハイブリッド

あなたがすること

*This position is for replacement of maternity leave for one year. ( ~ Jul, 2026)

What you will do

Act as Local Nominated Person (including back-up nominated person)

  • Function as nationally nominated person for Pharmacovigilance in respective countries assuming the PV role as defined by national law. Collaborate with the QPPV offices as required.

Oversight of the PV System & Overall responsibilities

  • Provide oversight of vendor resources in the countries in scope.
  • Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
  • Support the Area Safety Head in providing relevant local information for the European Economic Area/UK Pharmacovigilance System Master Files while collaborating with the global team to meet requirements for local PSMFs if applicable

Safety Management & Reporting

  • Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements.
  • Maintain oversight on day-to-day adverse Drug Reaction events inbound and outbound reporting as applicable in the given territory.
  • Responds to safety-related health authority queries in the territory.
  • Collaborating with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.
  • Collaborate with the local and global teams to ensure pharmacovigilance compliance of local company sponsored programs and research activities.
  • Perform translation for ICSR and PV-related documents, as required.

Collaboration & Support

  • Provide technical and strategic input and participate in projects/ workstreams led by the KMS teams or LOC.

Procedural Document Management

Audit & inspection readiness

PV contract management

Business Continuity Management

What we are looking for

  • Health care science professional (preferably Physician or Pharmacist)
  • +7 years of relevant experience
  • Pharmaceutical industry experience including product vigilance responsibility role
  • Ability to organize workflow activities and manage multiple critical issues
  • Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology
  • Expert knowledge of global, regional, and local procedural documents as applicable
  • Computer literate with knowledge of relevant IT safety systems
  • Ability to establish and maintain open relationships within the organization and with authorities
  • Demonstrable knowledge of all local requirements and of global aspects of product safety
  • Fluency in the national language(s) and the English language.

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