PV specialist/Sr. Specialist PV（外资医药，三方合同）

要求：英文听说很好， 留学背景加分。一年以上的PV经验。

1-
Act as Local Nominated Person/Local PV Responsible Person
(including back-up nominated person)


作为中国指定人员/药物警戒负责人（包括后备指定人员）


Function
as nationally nominated person for Pharmacovigilance/Local PV Responsible
Person in respective countries assuming the Pharmacovigilance and/or
Cosmetovigilance and/or Technovigilance role(s), if applicable, as defined by
national law. Local Nominated Person/Local PV Responsible Person and their
designated backups must ensure 24/7 availability within the countries where
they are nominated in, if required by national law. Collaborate with the QPPV
offices as required.
作为在中国指定人员/药物警戒负责人，按照中国法律法规的规定，承担药物警戒、化妆品警戒、器械等其他产品的警戒相关职责。中国指定人员/药物警戒负责人及其后备指定人员应确保全天候（24/7）保持联络畅通。同时按需与QPPV办公室紧密合作。







2-
Safety Management & Reporting


安全性管理和报告


·
Perform regulatory monitoring for
impact on vigilance activities and responsibilities.


对影响警戒活动和职责的法规进行监测。


·
Perform reconciliation
with other departments (distributors, third parties, vendors, and internal
stakeholders).


与其他部门（分销商、第三方、供应商和内部利益相关者）进行数据核对。


·
Perform medical
assessment as applicable.


进行医学评估（若适用）。


·
Maintain oversight of
proper identification of local literature articles for AE reporting as
required.


按法规要求正确识别在中国文献中的AE报告活动进行持续监督。


·
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. 向中国卫生监管机构和公司其他部门上报或递交相应的安全性报告、安全性更新报告和安全性信息（例如SAE、SUE、SUSAR、PSUR、RMP）。


·
Receive
and support the Area Safety lead in the responses to safety-related health
authority queries in the territory.


接收并协助中国产品安全经理答复中国卫生监管机构提出的与安全性相关的质询。


·
Supporting Area Safety
Lead in notifying local health authorities of any safety issues including
SSI/ESI and Signals.


协助中国产品安全经理向中国卫生监管机构上报相关安全性问题（包括 SSI/ESI 和信号）。


·
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.


持续更新中国药物警戒、化妆品和器械警戒的最新法规要求，包括报告要求（管辖范围内的所有产品类别），并与全球团队合作实施新要求所需的流程更新。


·
Record self-identified
non-conformances and collaborating with the global team to investigate
non-conformances while developing and implementing effective CAPAs.


记录自我识别的不合规项，并与全球团队合作调查不合规项，同时制定和实施有效的CAPA（纠正和预防措施）。


·
Perform other agreed
tasks assigned by manager.


完成经理交办的其他工作。


·
Perform document
management and archiving as required.


按要求进行文件管理和归档。


·
Perform training on
safety reporting responsibilities of LOC personnel and maintenance of awareness
of safety reporting in general.


对 LOC 人员的安全性报告职责进行相应的培训，保证LOC全员的整体安全性报告意识 。


·
Perform translation
for ICSR and PV-related documents, as required.


按要求翻译
ICSR 和 PV 相关文件。




70%


3- Procedural Document


程序性文件


·
Develop, update, and implement local procedures to ensure
compliance with Kenvue global procedures and national requirements.


制定、更新和执行中国程序性文件，以满足公司流程和管辖范围内法规要求。


·
Ensure current knowledge of all relevant company
procedures and training.


确保了解公司现有程序性文件的要求和培训要求。




5%


4-
Audit & inspection readiness


审计和检查准备


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.


支持中国卫生监管机构在中国进行的检查和审计，包括在检查和审计期间回复质询，并与全球团队合作制定和实施相应的CAPA（纠正和预防措施）计划。




5%


5-
PV contract management


药物警戒合同管理


Provide PV clauses
to be included within local agreements.


在中国协议中的提供适用的 PV 条款。




15%


6-
Business Continuity


业务持续性


Ensure
implementation of local business continuity plans (e.g., inspection
readiness, AE reporting coverage).


确保实施中国业务持续计划（例如检查准备、AE 报告覆盖范围）。




5%





Other Duties: 其他职责
Describe important
tasks or duties, not mentioned above, that are performed infrequently and are
not critical to accomplishing the essential functions of the job. Enter “N/A”
if no additional duties need to be listed.


描述上文未提及的、不经常执行的、对完成工作基本职能并不重要的重要任务或职责。如果无需列出其他职责，请输入 “N/A”。





N/A





Qualifications: 资质要求
Describe the minimum knowledge, skill, related experience, and ability
requirements for the position.


描述该职位的相关专业知识、技能、相关工作经验和能力要求。


Education: 教育背景


Health care science professional e.g.: (nurse, pharmacist, life
science degree) or equivalent training and experience


医疗保健科学专业（如护士、药师、生命科学学位）或具有同等教育的培训和经验。


Years
of Related Experience: 相关经验年限


1-2 years of relevant experience.


1-2 年相关工作经验。


Knowledge,
Skills, Abilities:
Include any required computer skills, certifications, licenses, languages,
etc.


包括计算机技能、资质、职称和语言等要求。


·
Pharmaceutical industry experience including product
vigilance responsibility role.


要求具有制药行业经验，包括从事过药物警戒相关工作。


·
Sound knowledge of general medicine, pharmacy, and
clinical practice, or another relevant scientific/medical field.


具备普通医学、药学和临床医学或其他相关科学/医学领域的专业知识。


·
Sound knowledge of medical terminology.


具有良好的医学知识。


·
Computer literate.


掌握相关信息化系统的计算机能力。


·
Good verbal and written communication skills.


具有优秀的口头表达和书面沟通能力。


·
Ability to establish and maintain
open relationships within the organization and with authorities.


具有与内外部（包括监管机构）建立和维护良好关系的能力。


·
Fluency in the national language(s) and the English
language.


母语和英语流利。