Global Pharmaceutical industry／外資系製薬会社

Pharmacovigilance Senior System Maintenance Expert ｜ファーマコビジランス シニアシステムメンテナンスエキスパート
■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 & outbound via E2B), tracking of E2B acknowledgements for those reporting and CAPA handling in case of incompliant reporting
-for maintaining the dictionary of all code lists, studies including non-company studies for which PV will have to maintained (before and after un-blinding if applicable)
■Configuration and maintenance of E2B R2 & R3 Mappings (inbound and outbound)for the electronic exchange of Individual Case Safety Reports (ICSRs) with health authorities, license partners and internal systems
■Maintenance of case distribution matrix including the list of all reporting destinations as well as the reporting rules per product and recipients (PV country heads through affiliate module, external partners, study teams, etc.)
■To drive, create and maintain case save procedures, data quality checks with health authorities and license partners world wide
■PV systems changes, incl. preparation and execution of change controls (like IQ,OQ,PQ)
■To support the global PV access management, incl. maintenance of Sites, Users and Groups

■Bachelor's Degree or above
■Or master degree in Information Technology plus 5 or more years of pharmacovigilance experience
■Profound knowledge of PMDA/CFDA regulations and guidelines
■Enhanced experiences with the maintenance of a globally operated system for Pharmacovigilance.
■Extensive knowledge of drug safety processes
■Required - Maintenance of E2B-configuration within a global PV System, maintenance of a PV product dictionary and related data

Working Location: Western part of Japan (Osaka)|勤務地：関西エリア（大阪）