Pharmacovigilance and Medical Information Manager

Major Responsibilities：

• Local Safety Officer responsibilities
• Management, collection, recording and filing of all the Adverse Events and Adverse Reactions received in the country on investigational drugs and marketed products according to Global Corporate Safety and Pharmacovigilance (GCSP) SOPs, local SOPs and local Health Authorities regulations
• Reporting to the Regulatory Authorities of all adverse drug reactions, adverse events, Periodic Safety Update Reports and any other information that should be reported according to internal proceedings or law
• Review local and international regulations concerning Pharmacovigilance and conformance of GCSP SOPs and Company’s general proceedings with China laws on Pharmacovigilance and Good Clinical Practices
• Review and update of Standard Operating Procedures on Pharmacovigilance
• Assurance of Company Compliance to Drug Safety regulations and internal SOPs
• Updated maintenance of relevant data bases for Adverse Drug Report recording
• Training of Company personnel in pharmacovigilance duties
• Attendance and contribution to internal/external meetings on Pharmacovigilance
• Information exchange regarding to Corporate Drug Safety Department and affiliates
• Responsibility for implementing and maintaining quality assurance and quality control systems with written SOPs within Medical Affairs and Pharmacovigilance areas, to ensure that proceedings are conducted and data are generated, documented and reported in compliance with the protocol, GCP, and applicable regulatory requirements
• Assessment and supervision of quality assurance and quality control systems of other areas of the Medical Department, specially related to updating of related SOPs and providing regular training to relevant company staff.
• Interface within medical department with local and Global Medical Affairs Quality and Business Improvement department to ensure that quality procedures are performed
• To respond (verbal and written replies) to technical/medical questions from healthcare professionals and internal customers by the retrieval, evaluation and presentation of high quality information using in-house and external sources in a timely and efficient manner
• Analysis of Bibliographic & Medical Information sources
• Maintain the Medical Information database  in close collaboration with Medical Advisors for therapeutic areas
• Use and adapt global standard responses and generate UCB China standard responses in line with the relevant SOPs
• Interface with colleagues from Global Medical Affairs concerning medical information activities- represent UCB China in relvant forums.

Requirement：

• MD
• M.S. or PhD in a life science
• M.S or PhD in Pharmacy or pharmacology
• Excellent English and Chinese
• Three or more years experience in the pharmaceutical industry within Technical-Medical Departments.
• Knowledge of GCP and ICH Guidelines