崗位職責(zé)：
?Ensure all AE are collected through PV maintained channels,including but not limitedto PV Mailbox, PV website, fax, Literature, etc. to ensure spontaneous AE can be reported to AZ any time.
?Manage the PV ICSR reporting and submission activities including: Individual AE report handling, CFDA batchcase handling, Internal/vendor caseQC, etc; to ensure the quality and compliance.
?Manage the PV periodic safety reporting activities including, Foreign ADR LineListingsubmission, Study SUSAR Line Listing, PSUR/PBRER submission;to ensure the quality and compliance.
?Distribute safety information to study management team.
?Maintain product list, ISL, KUR, SSI and any China specific PV system to support ICSR or period reporting handling and submission. Be back up for team members.
?Monthly AE reconciliation with cross functional team which has interaction onAE reporting.Implement of Licensing Agreements.