·Lead Pharmacovigilance China team with processing of adverse event/drug experience reports (serious and non-serious) and other safety related data for marketed products and clinical trials to ensure high quality case reports and submissions compliance.

·Provide functional oversight over clinical trial and post-marketing pharmacovigilance processes.

·Assist to direct project start-up team to ensure timely and accurate completion of start-up tasks including review of study documents, reports, marketing brochures, and

others as applicable.

·Set up case processing process for clinical trials including consultation with NMPA and coordination with CRO.

·Maintain PV database including system update according to strategy and international regulation.

·Provide in-depth technical expertise on Pharmacovigilance processes and systems.

·Assist with directing CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.

·Assist to support audit and inspection processes as required, including serving as functional subject matter expert as required.

·Manage resource management processes for assigned teams, including recruitment of staff, line management of assigned staff and succession planning.

·Ensure compliance with Pharmacovigilance data reconciliation processes, and work to resolve/escalate issues as appropriate.

·Develop procedures (SOPs, Job Aids), forms and templates in support of efficient case management processes.

·Develop staff in assigned functional Pharmacovigilance processes, project and team management, and encourage growth by provision of regular mentoring and performance feedback.

·Assist with vendor oversight, including identification of out of scope needs, quality and resourcing issues, and escalation of issues as appropriate.

·Direct and ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.

·Ensure files and systems are maintained as appropriate.

·Oversight and direction of additional tasks and projects as assigned by senior management.

·Support Senior Management as required.

·Bachelor's degree or educational equivalent in health science or other directly related field or equivalent combination of education, training or experience.

·Safety database system expert (Argus is preferred).

·Expert knowledge of domestic and global Pharmacovigilance regulations (GCP/GVP/GPSP), CDE?NPMA/FDA/EMA regulations, ICH Guidelines.

·Demonstrated leadership ability.

·Demonstrates accountability and responsibility for both director role and assigned team.

·Minimum of 5 years global pharmacovigilance. experience or other equivalent clinical or pharmaceutical industry experience.

·Minimum of 3 years people management experience.

·Minimum of 5 years global pharmacovigilance. experience or other equivalent clinical or pharmaceutical industry experience.

·Minimum of 3 years people management experience.

·Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).

·Expert organizational, time management, and problem-solving skills.

·Advanced project and staff management skills.

·Flexibility, adaptability and Positive attitude.

Contact Person：Frank Wang

Mobile：15680922101

Mail：frank.wang@isaac-kenneth.com