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PV Liaison

Plats Shanghai Downtown, Shanghai Shi, Kina Jobb-id R-083791 Datum inlagd 06/09/2020

Job Summary

The 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 archiving

Patient 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

Training

Deliver 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.



AstraZeneca 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 authorisation and employment eligibility verification requirements.

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