Primary Job Function

The primary function of the IT/Safety Documentation Specialist is to provide non-technical business support and coordination with the IT department regarding standard (non-validated) applications (e.g. MS Windows, MS Office) and computer hardware, as well as Abbott systems (e.g. DARIUS, SharePoint sites owned by GPV, shared drives). The Safety Documentation Specialist is responsible for document management, formatting and archiving of periodic reports and medical safety documents (e.g. Health Hazard Assessments, signal evaluation reports) and ensures accurate distribution of all Medical Safety Documents to internal stakeholders, Affiliates and License Partners.

Core Job Responsibilities

• IT Key-User accountable for IT supply and infrastructure within GPV regarding standard applications.
• Represents GPV IT needs and serves as a single contact point for Helpdesk/IT representatives
• Is responsible for the IT on- and off-boarding of GPV staff.
• Works collaboratively with cross-functional counterparts on IT
• Has a deep understanding of company specific IT processes and standards.

• Distributes Medical Safety Documents
• Communicates and publishes each version of Global Periodic Safety Report Timetable.
• Accurately processes (including eCTD formatting), distributes and archives periodic safety reports and Risk Management Plans of the Periodic Reporting and Medical Writing Group per department procedures within specified timeframes to ensure compliance with global safety regulations and best practices.
• Acts as GPV Business Administrator for the DARIUS Document Management System.
• Manages PV System & Compliance specific documents in DARIUS and has an oversight on GPV documents and their archive location.
• Sets up, maintains, and manages existing document-specific common drives and company electronic archives.
• Coordinate between PV contract owner and PV service provider for PV contract draft, review and finalization

Supervisory/Management Responsibilities:

Direct Reports: 0

Indirect Reports: 0

Position Accountability/Scope:

• Is accountable for departmental specific IT requests and system updates.
• Accountable for the timely processing, formatting, distribution and archiving of safety reports.
• Works with supervision and guidance.

Minimum Education:

• Industrial business management assistant, documentation specialist or alike

Minimum Experience/Training Required:

• Minimum 3 years on the job experience in the industry.
• Advanced knowledge of standard IT procedures, very good project management skills.
• Experienced professional in the use of Microsoft Excel, Word, Power Point, Outlook, HTML, SharePoint and e-room technology as well as good eCTD knowledge and formatting skills
• Very good communication and presentation skills (oral and in writing) in English.
• Position requires strong multitasking and organizational skills, detail oriented.
• Advanced knowledge and understanding of PV specific terminology and reporting requirements.
• Experienced in Document Management.