Safety Documentation Specialist

The primary function of the IT/Safety Documentation Specialist is to provide non-technical business support and coordination with the IT department regarding standard applications such as MS Windows, MS Office, and Abbott systems like DARIUS and SharePoint sites. You will be responsible for document management, formatting, and archiving of periodic reports and medical safety documents, ensuring accurate distribution to internal stakeholders, Affiliates, and License Partners. As the IT Key-User, you will be accountable for IT supply and infrastructure within GPV related to standard applications. You will represent GPV IT needs and serve as a single contact point for Helpdesk/IT representatives. Additionally, you will handle the IT on- and off-boarding of GPV staff and work collaboratively with cross-functional counterparts on IT matters. It is essential to have a deep understanding of company-specific IT processes and standards. Your responsibilities will also include distributing Medical Safety Documents, communicating Global Periodic Safety Report Timetables, processing, distributing, and archiving periodic safety reports and Risk Management Plans, ensuring compliance with global safety regulations. You will act as the GPV Business Administrator for the DARIUS Document Management System and manage PV System & Compliance specific documents in DARIUS. Furthermore, you will set up, maintain, and manage document-specific common drives and company electronic archives. You will coordinate between PV contract owner and PV service provider for PV contract draft, review, and finalization. In terms of qualifications, the role requires a minimum of 3 years of industry experience and advanced knowledge of standard IT procedures and project management skills. Proficiency in Microsoft Excel, Word, Power Point, Outlook, HTML, SharePoint, e-room technology, and eCTD formatting is necessary. Strong communication and presentation skills in English, multitasking abilities, organizational skills, attention to detail, and understanding of PV specific terminology and reporting requirements are essential. Experience in Document Management is also preferred.,