Labelling Development Support

at  Cognizant Technology Solutions

Job location: Budapest, Hungary, 9thDistrict, Mill Park Office Building
Role type: Full-time employment
Working hours: 40 hours/ week
Office attendance once per week
Normal office hours

REQUIREMENTS

• Language Capability: Good spoken and written English
• Minimal Education Qualification: Life science/pharmacy graduate (university degree)
• Min. 5 years of relevant work experience

DESCRIPTION

• Review, update and project management activities for CCDS implementation workflow based on assignments provided by BI.
• Access information provided in notification form and CCDS
• Review of CCDS notification form
• Triage deviations (known vs. unknown deviations) in line with available notification form history for notification forms with implementation status “partially” and “not possible to implement”
• Review deviations
• Escalate deviations to Global Labelling Team
• Follow-up escalation process e.g. feedback to LRA on result of escalation etc.
• Coordination with Global Labelling and Local Regulatory Teams
• Creation of CCDS implementation workflows for EEA in CPD3
• Updating EEA notification form (CNO) based on tracked EU SmPC and information provided by GL manager and/or Global Regulatory Affairs manager
• Compliance with SLA
  Employee Status : Full Time Employee
  Shift : Day Job
  Travel : No
  Job Posting : May 10 2024

Please refer the Job description for details