上海招聘

职位描述：

1）医药或生物相关专业本科以上学历；

2）6~8年以上工作经验，其中4年以上PV相关工作经验，丰富的项目管理经验；

3）良好的沟通能力，有PV药品安全项目 database搭建经验优先；

4）英语听说读写熟练，未来汇报给外国人。

Job Summary

This is a role that requires to maintain the local PV system in terms of structure and performance to ensure compliance with regulatory requirements and global procedures. This role includes not only local PV activities but also communicate and collaborate with global PV functions and will directly report to the Head of global PV function in charge of local PV system management.

Key Responsibilities

Safety Reporting (ICSR)

Collect and report the Safety Information to Global Pharmacovigilance according to relevant SOPs.

Perform follow-up on Safety Reports, including Pregnancy cases, as per relevant SOPs/WPs.

Safety Reporting (Significant/Emerging Safety Issue)

Report the significant, emerging safety issues to the Health Authority as required.

PV Training

Conduct local PV trainings for employees and vendors.

Participate in PV trainings organized by global PV.

Maintenance of Local PV SOP

Develop and maintain local PV SOP to ensure compliance with the requirements.

Aggregate Report

Submit the required Aggregate Reports (e.g., PSUR, PBRER, and/or DSUR) to the applicable local regulatory authorities, if required.

Risk Management Plan

Oversight of local Risk Management Plan (RMP), if required, including generation of local RMP documents, submission to the applicable health authorities, implementation of approved RMP model.

Local Literature Search

Identify Safety Information detected by local literature search and report it to global PV.

Interface with Other Functions

Safety information reconciliation with relevant team such as Product Quality Complaint and Medical Inquiries.

Work on PV-related CAPA management.

Regulatory Intelligence

Maintain current knowledge of all local regulatory PV requirements in the Territory.

Others

Manage responses to PV-related queries from health authorities.

Manage PV audit/inspection readiness and responses in collaboration with relevant global functions.

Interaction with Global PV

Escalate potential gaps or issues to global PV.

Participate into the activities organized by global PV.

Qualifications and Competencies

- Bachelor degree or above of Pharmacy or life science related fields

- Minimum 4 year experience in PV-related areas is preferred

- Speak and write English to good standard

- Ability to develop and interpret policies and to perform multiple tasks

- Strong analytical, interpersonal and communication skill

知名外企业务，工作环境好，良好的培训和职业晋升空间。

双休，五险一金，商业保险，带薪年假病假。

联系方式如下：

联系人：Kitty Yang

手机号: 13478553381

电话：0411-39707283

电子邮箱：Kitty@china-genius.com

公司成立于2008年，是大连最早、***的人力资源、活动策划服务公司之一。自成立以来一直致力为企、事业单位提供高端活动策划服务；“创新、服务”是展锋公司的立业之本，经过多年的努力，我们已形成一套完整的设计、沟通、执行、跟踪一站式服务体系。展锋文化传媒为企业客户提供：拓展训练、企业年会/庆典、企业家庭日、企业运动会、大型赛事及企业会务会展承办等服务。