Safety Liaison

AstraZeneca

China
Permanent
Full-time

13 days ago

Job SummaryThe China (senior) PV Specialist is responsible for safety data management and submission, PV system management, providing training to AZ staffs and/or vendors and to be the partner with cross-functional team and external customers.This role should understand company’s code of conducts& compliances policies& China PV Regulations, and to manage the daily activity to align with these accordingly.DUTIES & RESPONSIBILITES / 主要职责ICSR (individual case safety report) management

Individual AE report handling, from all sources: clinical studies, spontaneous, literatures, etc:

- Data review, coding, translation and communication- Report to global Data entry site- Report to CFDA- Query answering- Tracking and archiving- Late case communication and CAPA report

CFDA batch case handling

- Data review, coding, translation or validation- Report to global Data entry site- Query solving- Case synchronization

Internal/vendor case QC

- Data entry accuracy, integrity and timeliness- Documentation archived completeness and timeliness- Case tracking log accuracy and timeliness- CIOMS download and clean up timely- Global Data entry site queries respond timely- ADR system queries response timely- Late case communication and CAPA report accomplish

Generate routine and ad hoc reports to support pharmacovigilance activities and regulatory reporting requirements.
Vendor management
Be back up for team members

Periodic Safety reports management

Monthly Line Listing submission

- Translation validation- Upload to ANGEL- Submission- Tracking and archiving

Study SUSAR Line Listing

- Translation validation- Upload to ANGEL- Submission- Tracking and archiving

Distribute safety information to study management team and keep tracking.
PSUR/PBRER submission

- Translation validation- Upload to ANGEL- Submission- Tracking and archivingPatient Safety quality compliance

Monthly AE reconciliation with cross functional team which has interaction on AE reporting
Review and Operational input of Licensing, Clinical Safety Agreements and SHP (safety handling plan)
Work with business partner to ensure business activities (e.g. Market Research and Patient-Centric programs) to determine operational pharmacovigilance requirements (contracts, training, issue resolution) ensuring compliance with regulations

TrainingDeliver safety training to ensure full safety compliance

AE awareness training to new staffs
AE awareness training to vendors
Refresh training to the staffs who has stay in AZ more than 1 year

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.Date Posted 15-4月-2024Closing Date 14-7月-2024AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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