Safety & PV Specialist I (ICSR Processing + MedDRA Coding) - Hybrid

About the role

Syneos Health is hiring a Safety & PV Specialist I in Budapest on a hybrid basis. The role covers the collection, processing and reporting of individual case safety reports (ICSRs), literature screening for safety, drug coding and data management within a clinical trial or postmarketing safety programme.

Key responsibilities

• Assist with safety and pharmacovigilance programme delivery, including collection, processing and reporting of ICSRs
• Screen and review literature for safety signals
• Clean and validate data, including the xEVMPD product dictionary and manual recoding of substance and product terms from ICSR reports
• Maintain the MedDRA coding and manage duplicate ICSR cases
• Perform quality review of ICSRs and prepare expedited and periodic safety reports
• Carry out SPOR and IDMP activities
• All work must follow data privacy guidelines, GCP, GVP, regulatory guidelines and project-specific procedures

The company states that the listed duties are not exhaustive and that equivalent experience, skills or education will be considered.