Kenvue 目前正在招聘 a：
我们做什么
在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。
我们是谁
我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.
Role reports to：
ASPAC Regional Head, Local PV位置：
Asia Pacific, Japan, Tokyo-To, Chiyoda工作地点：
完全现场你会做什么
This position reports into APAC Regional Head and is based at Tokyo, Japan.
POSITION SUMMARY: The Country Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.
**Key Responsibilities**
1.Act as Local Nominated Person (including back-up nominated person)
Function as nationally nominated person for Pharmacovigilance in respective countries assuming the Pharmacovigilance and/or Cosmetovigilance and/or Medical Device Vigilance role(s), if applicable, as defined by national law.
Local Nominated Person and their designated backups must ensure 24/7 availability within the countries where they are nominated in, if required by national law.
2.Safety Management & Reporting
Perform regulatory monitoring for impact on vigilance activities and responsibilities.
Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
Maintain oversight of proper identification of local literature articles for AE reporting as required.
Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Kenvue departments as applicable.
Receive and support the Area Safety lead in the responses to safety-related health authority queries in the territory.
Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals.
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.
Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
Perform other agreed tasks assigned by manager.
Perform document management and archiving as required.
Perform training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
Perform translation for ICSR and PV-related documents, as required.
Manage / Maintain oversight of the reporting and submission of safety reports, updates, and other safety-related information (e.g. AE, SAE, SUE, SUSARs, PBRER, DSUR, PSUR, RMP) for medicines, cosmetics, and/or medical devices to local health authorities and relevant Kenvue departments, as applicable.
3.Procedural Document
Develop, update, and implement local procedures to ensure compliance with Kenvue global procedures and national requirements.
Ensure current knowledge of all relevant company procedures and training.
4.Audit & inspection readiness
Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable.
5.PV contract management
Provide PV clauses to be included within local agreements.
6.Business Continuity
Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).
What we are looking for
**Required Qualifications**
Education: Health care science professional e.g.: (nurse, pharmacist, life science degree) or equivalent training and experience
Years of Related Experience: 1-2 years of relevant experience.
Knowledge, Skills, Abilities:
Pharmaceutical industry experience including product vigilance responsibility role.
Sound knowledge of general medicine, pharmacy, and clinical practice, or another relevant scientific/medical field.
Sound knowledge of medical terminology
Computer literate.
Good verbal and written communication skills.
Ability to establish and maintain open relationships within the organization and with authorities.
Fluency in the national language(s) and the English language.
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