Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting for a
Global Regulatory Affairs Operations Innovation and Information Management Associate
The resource will ensure the proper product data governance activities, continuous updating and compliance checks of the regulatory database. He/she will manage system issues and relevant fixes validation.
He/she will be responsible of the management of xEVMPD (extended EudraVigilance Medicinal Product Dictionary) tasks and will provide an active contribution to cross functional/department activities for the development of other tools with interaction with the regulatory database.
MAIN ACTIVITIES AND RESPONSIBILITIES
Uploading into the system of product/registration details based on information received from the colleagues owners of the data including product data governance;
Evaluates system improvements and participates to cross functional/department activities for the development of other tools with interaction with the regulatory database;
Finalizes and distributes Working Instruction and training material to users (issue and relevant periodic review);
Manages CAPA in case of incorrect data and performs relevant data amendments;
Performs corrections/amendments in the system;
Provides support to Regulatory Database users (whether they are identified as Verification or Read Only)
Manage xEVMPD data including transmission to EMA and relevant data checking in EudraVigilance upon successful completion of the xEVMPD knowledge evaluation;
Analysis of xEVMPD guidelines and periodic monitoring of new documents issued by EMA authority;
Interaction with other company departments part of the xEVMPD team within the Company for the relevant data governance and verification;
Interacts with the IT specialists on the system settings and evaluation of system bugs or technical issues;
Validates bug fixings upon Vendor/IT intervention on the software, by performing specific validation tests
JOB REQUIREMENTS
Master degree or higher in scientific fields
Good spoken and written English
The candidate should have good communications skills
Contract type: fixed term contract 12 months
Location – Florence, hybrid position
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