Title:Sr. Specialist, Local Medical Safety Oversight
隶属:Johnson & Johnson Innovative Medicine(杨森)
Base:北京,华贸
隶属PV团队:Local PV- Quality & Compliance Team
项目周期:1年(不会续签)
12个月Total含税预算:2.5W*13
项目介绍:
2025年西安和北京的2次外审。
PV维度的供应商管理项目。
招人要求:有2年+PV相关经验,英语口语熟练,PPT能力。
日常工作内容,无需该Contractor独立负责项目,主要是PV内部合规和质量项目的支持工作,政府监管部门的检查(外审)-文件翻译的Review,整理新的PV法规及执行等。
Essential Job Duties: Briefly state the objective of this position. (TYPE BELOW THIS LINE)
Ensuring that the Local Operating Company (LOC) safety activities, related to medicinal products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any Pharmacovigilance (PV) agreements with third party business partners.
Having appropriate pharmacovigilance risk management systems and adequate record management in place to assure appropriate oversight for products within its responsibility.
Managing Local Medical Safety activities to:
Ensure proactive Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs.
Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.