Safety Documentation Specialist

Primary Job Function

The Safety Documentation Specialist is primarily 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

• Distributes Medical Safety Documents
• 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 GPV 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.
• Member of back-office before and during PV inspections and audits of GPVs PV system.
• Deputy PSMF Coordinator
  • Maintenance of the Pharmacovigilance System Master File (PSMF)
  • Providing PSMF or related information upon request

Minimum Education:

• Industrial business management assistant, documentation specialist or alike

Minimum Experience/Training Required:

• Minimum 3 years on the job experience in the industry.
• 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.