(Senior) PV Manager

Major Responsibilities：

• SOP change implementation Communicate and train PV SOP change to local functional groups and PV staff and update local PV LWI. PV intelligence Communication analysis impact of PV regulatory update to functional groups at local/regional/global level. Audit and inspection readiness Lead and coordinate functional groups to prepare for audit and inspection. CAPA and follow up action plan. PV staff orientation Provide orientation training to new PV staff. Interface management Manage routine interaction with local functional groups, e.g. PV-MA platform. PV refresh training and PV awareness Be responsible for PV refresh training and take action to improve PV awareness in the OPU. PVA negotiation and management Negotiate local PVA and implement global/regional PVA per relevant SOP Supervise daily PV operation Ensure daily PV operation are conducted according to PV internal standard.

Requirement：

• Deep understanding of China and international PV regulation and guidline
• Medical doctor/Pharmcist/nursing
• at least 5 years PV experience, including at least 3 years in multinational pharma PV function.