PV Operation Manager

Major Responsibilities：

• Support the Head of PV in all Pharmacovigilance activities including audits and regulatory inspections.
• Assume the responsibility of providing the leadership, management, building up teamwork, coaching the PV operation team.
• Ensures that collection, reporting and handling of safety information from all sources (including data entry into Advent database, company or investigator initiated clinical studies, spontaneous and literature reports) associated with Roche products is performed in compliance to China regulatory and the company SOP requirement.
• Ensures accurate and timely reporting of single, expedited reports and safety analysis of aggregate safety data as required by China SFDA.
• Responsible for providing safety input in China for internal customers and works with regulatory, legal, public relations, medical information and clinical study teams for responses to safety queries from China regulatory agency, media, patients, medical community and investigators.

Requirement：

• Strict implementation process
• Strong communication and coordination ability with cross departments/units
• Leadership
• PV expertise
• 3-5 years working experience in PV with previous managerial experience
• Excellent written and spoken English and Chinese with communication skills
• Computer literacy