Area Safety Lead (PV 약물 감시 - 계약직 채용)

Area Safety Lead (PV 약물 감시 - 계약직 채용)

Что мы делаем

At Kenvue, мы осознаем необычайную силу повседневной заботы. Основанный на более чем вековом наследии и уходящий корнями в науку, мы являемся домом культовых брендов, включая NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® и BAND-AID®, которые вы уже знаете и любите. Наука – наша страсть; забота – это наш талант.

Кто мы

Наша глобальная команда – это ~ 22 000 блестящих людей с культурой рабочего места, где каждый голос имеет значение, а каждый вклад ценится. Мы увлечены идеями, инновации и стремление поставлять нашим клиентам лучшие продукты. Обладая опытом и эмпатией, быть Kenvuer означает иметь возможность влиять на миллионы людей каждый день. Мы ставим людей на первое место, заботимся о настолько, завоевываем доверие наукой и смело решаем – и вас ждут блестящие возможности! Присоединяйтесь к нам, чтобы формировать наше будущее и ваше. Для получения дополнительной информации, нажмите here.

Role reports to:

Area Safety Lead, South Korea, HK &TW

Местонахождение:

Asia Pacific, South Korea, Seoul, Seoul

Место работы:

Гибрид

Что ты будешь делать

*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.

Если вы являетесь человеком с ограниченными возможностями, пожалуйста, ознакомьтесь с нашим страница помощи инвалидам для получения информации о том, как запросить приспособление.