Description
Syneos Health is seeking a Safety & PV Coordinator II - Data Management in Budapest. As a member of the Clinical Solutions team, you will assist with safety and pharmacovigilance program delivery activities, including collection, processing, and reporting of individual case safety reports (ICSRs), literature screening and review for safety, drug coding, and data management activities.
Responsibilities:
- Assist with safety and pharmacovigilance program delivery activities
- Collect, process, and report ICSRs
- Conduct literature screening and review for safety
- Perform drug coding and maintain drug dictionary
- Manage data, including cleaning and validation
- Prepare expedited and periodic safety reports
The ideal candidate will have experience in a similar role and knowledge of Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and regulatory guidelines.