R&D - Associate PV Operations Manager - SH

1. Our position

• Job title:副经理Associate PV Operations Manager
• Grade: L2-2
• Hiring Manager:Yuting Chen
• Location:上海Shanghai

2. About the job

该职位负责确保本地PV运营活动符合患者安全与药物警戒（PSPV）政策以及全球、和本地PV法规，以保证赛诺菲产品在中国的安全和合理的使用。

This position is responsible for ensuring local PV operation activities are performed in compliance with the PSPV (Patient safety & Pharmacovigilance) policies, as well as global, and local PV regulations to warrant safe and appropriate use of Sanofi products in China.

主要利益相关者

• 内部团队：与全球PSPV团队、本地PSPV团队、注册事务部，质量部等密切合作。
• 外部合作伙伴：与外包服务提供商、监管机构等保持良好沟通

Key stakeholders:

• Internal Teams: Work closely with the global PSPV team, local PSPV team, regulatory affairs team, quality team, etc.
• External Partners: Maintain good communication with outsourced service providers, regulatory authorities, etc.

主要工作职责包括：

• 负责各来源AE/SAE的接收，处理，传递，随访和递交；
• 确保制订定期安全性更新报告的计划和及时递交；
• 及时处理和回应药监的审核意见；
• 支持直线经理监测外包PV运营活动的质量和合规性；
• 确保PV系统的本地运行，维护PSPV部门的质量文件，包括创建和更新质量文件，等。

Main responsibilities include:

• Responsible for AE/SAE intake, processing, transmission, follow up and submission from differences sources,
• Ensure complete periodic safety report plan and timely submission of periodic safety report,
• Timely handle and response for the review comments from health authority,
• Support line manager to monitor the quality and compliance for out-sourced PV operational activities,
• Ensure PV system runs properly locally. Maintains quality document of PSPV department, including creating and updating quality document, etc.

3. About you

• 教育Education：

药学、护士或相关专业硕士或学士学位

Pharmacy, Nurse or relevant Master or Bachelor’s degree

• 经验Experience：

至少拥有3年本地药物警戒活动经验

At least 3-year experience in local pharmacovigilance activities

拥有与监管机构互动的经验

Experience with Regulatory Agency interactions

具有解决问题和时间管理的技能，特别是在实施QD、操作手册和指导文件中所述的安全规则和全球规程方面。能够在压力下工作。

Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in ODs, Operational Manuals and Guidance documents. Capacity to work under pressure.

4. Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!