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.

Key responsibilities

• Process ICSRs according to SOPs, triage them, evaluate completeness and accuracy, and enter data into the safety database
• Code events, medical history, concomitant medications and tests, and compile narrative summaries
• Coordinate workflow, distribute workload and escalate issues to the Safety Program Delivery Lead or Line Manager
• Support risk management, prepare project plans such as the Safety Management Plan, and take part in project reviews
• Perform quality review of ICSRs, literature screening, drug coding, MedDRA coding, xEVMPD product records and SPOR/IDMP activities
• Manage duplicate ICSRs, coordinate data reconciliation between clinical and safety databases, and ensure reports reach the Safety Submissions team
• Train investigators and project team members on ICSR reporting, take part in audits/inspections, and ensure documents go to the TMF and PMSMF
• Act as a subject matter expert, mentor and coach, and may serve as Safety Program Delivery Lead for local or regional studies

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/or 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 medical terminology
• Microsoft Office (Word, Excel, PowerPoint), Visio, Outlook and TeamShare