Category

Description

Pharmacovigilance Senior System Maintenance Expert ??????????? ???????????????????
?Working evvironment
a team of technical Pharmacovigilance (PV) experts who are analyzing, maintaining PV reference information and establishing technical configuration of computerized global PV systems and other global satellite systems.
close co-operation with many global PV business functions world-wide on one side and with internal and external IT service providers and suppliers on the other side, to ensure that the global PV systems are kept consistent, operational and fit for purpose.
?To setup and to maintain of the dictionaries for Product, studies and registration information as well as electronic datasheets for Auto-labelling and code lists containing other data of relevance for the PV business.
?The responsibilities
comply with the relevant GxP process SAE reports(e.g. investigator led studies) - for every study the possible study treatments must be defined and standards and to document all configuration changes according to the validation rules set by these standards and by the respective pharmaceutical SOPs.
to keep the computerized pharmacovigilance (PV) system operational and fit for purpose. Supervise the maintenance of all reference data (reference tables) used by the system and the regular reconciliation of this data with other sources (e.g. BRAIN, Impact, PV Agreements with license partners)
for maintaining the dictionary of all products and licenses including development products and licenses, including the maintenance of datasheets for Auto-labelling in cooperation with PV risk management and PV data analysis
for the maintenance and support of a centralized PV reporting process for PMDA and CFDA (inbound

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