Safety Database Manager
TFS, Hungary

Safety Manager, Drug Safety is part of the Project Delivery organization and is responsible for management in Drug Safety/Vigilance and will work according to company policies, SOPs and regulatory requirements.

Key Responsibilities

• Maintenance of the Safety Database "Veeva Vault Safety"
• Creating and generation of ad-hoc reports from Safety Database
• Overall responsibility of the handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients’ SOPs and existing regulatory demands.
• Review and approval of AE/SAE reconciliation and safety coding
• Overview of safety activities in the department
• Responsible for plans/instructions and SOPs
• Overlook that assigned projects and tasks in the unit are performed in accordance with current routines, methods, SOPs (TFS or clients) and current legal requirements.

Requirements

• Bachelor’s Degree, preferably in life science
• Experience with life sciences data
• 10 years of relevant experience
• Nice to have: Previous experience with "Veeva Safety Database" or other Veeva platforms
• Understand the medical terminology and science associated with the assigned drugs and therapeutic areas
• Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs
• Excellent English written and verbal communication skills

Job Rewards and Benefits