The role and responsibility of the China Pharmacovigilance Physician (PVP) is to comply with company policies and fulfill China health authority requirements by:
- Responding to the continued safety assessment, evaluation and risk management of AZ products;
- Leading the drug intensive monitoring;
- Leading the risk management plan;
- Proactively evaluating the clinical implications of safety data from clinical studies;
- Leading the drug collaborate with cross-functional team and global safety organization;
There are 4 levels in PVP role, i.e. associate PVP, PVP, Sr.PVP and principal PVP.
PVP are expected to have ≥1 year’s experience as associate PVP and proven record of success (internally or externally). Sr. PVP are expected to have ≥2 years’ experience as PVP and proven record of success (internally and externally). Principal PVP are expected to have ≥2 years’ experience as Sr.PVP, basic coaching skill and proven record of success (internally or externally).
DUTIES &RESPONSIBILITES / 主要职责
Therapeutic area based product safety surveillance 70%
Closely monitor the responsible products’ safety profile in Chinese patients, including in clinical study phase and post market utilization.
Provide feedbacks to global Patient Safety organization; collaborate with global teams on product development and life cycle management from local safety perspective.
Serve as China Safety liaison to internal/external customers. Provide valuable inputs to partners from safety perspective to support
pipeline development and clinical study implementation
delivery of medical plan and brand plan
solving of litigation defense
Work out China risk management plan to specific products, and lead the cross-functional team to implement, manage the product safety risks in China market.
Ensure full compliance to regulations 30%
- Leading the delivery of Drug Intensive
- Monitoring plan to new products.
- Provide strategic input into China Authority submissions, queries, and discussions.
- Review the submission of various HA submissions, including PSUR/PBRER, Monthly overseas SUSAR line listing and any other HA submission.
- Ensure the quality of safety contents in China product label
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.