Senior Safety & PV Specialist (Hybrid) - Madrid

About the role

Syneos Health is hiring a Senior Safety & PV Specialist in Madrid on a hybrid basis, overseeing pharmacovigilance systems. The role covers the full cycle of safety reporting: collecting, processing and reporting individual case safety reports (ICSRs), literature screening, drug coding, data cleaning and validation, and preparing expedited and periodic safety reports, in line with GCP, GVP and regulatory guidelines. The specialist works with minimal oversight and coordinates the workflow of the project or programme.

Key responsibilities

• Process ICSRs according to SOPs, triage them, check completeness and accuracy, and enter data into the safety database
• Code events, medical history, concomitant medications and tests, and compile narrative summaries
• Follow up on queries until they are resolved
• Prepare expedited and periodic safety reports and coordinate with data management on reconciliation of safety data
• Maintain safety tracking, validate and submit xEVMPD product records, manage duplicates, and carry out quality reviews of ICSRs and peer work
• Support SPOR/IDMP activities, assist in the Safety Management Plan, and take part in project reviews
• Manage a small team, distribute workload, escalate issues, and train investigators and project team members on ICSR reporting
• Take part in audits and inspections, and ensure documents are submitted to the TMF and the PSMF

Required profile

• Bachelor's degree in life sciences, nursing, pharmacy or an equivalent combination of education and experience
• In-depth understanding of clinical trials (Phases II-IV) and post-marketing safety, ICH GCP, GVP and safety regulations
• Ability to work independently and in a team, with strong communication, organisation and attention to detail
• Minimal travel (up to 10%)

Required skills

• Safety database systems and knowledge of medical terminology
• Microsoft Office (Word, Excel, PowerPoint), Visio, Outlook and TeamShare