Safety Specialist – Mexico – Fluent Portuguese Required

About the role

Syneos Health is seeking a Safety Specialist to support pharmacovigilance activities in Mexico. The role involves processing and tracking individual case safety reports (ICSRs) and ensuring compliance with regulatory requirements.

Key responsibilities

• Enter and track ICSR data in PVG quality and tracking systems.
• Process, triage, and code adverse event reports, including medical history, concomitant medications, and test results.
• Compile narrative summaries, query missing information, and resolve queries.
• Generate expedited safety reports in line with regulatory timelines.
• Perform literature screening, maintain drug dictionaries, and conduct MedDRA coding.
• Validate and submit xEVMPD product records and manage duplicate ICSR identification.
• Maintain documentation in the Trial Master File and Pharmacovigilance System Master File.
• Participate in audits and apply regulatory intelligence to safety reporting activities.

Required profile

• Bachelor’s degree in life sciences, nursing, pharmacy, or equivalent experience.
• Understanding of clinical trial phases II‑IV and post‑marketing safety requirements.
• Knowledge of ICH GCP, GVP, and related pharmacovigilance regulations.
• Ability to work independently and collaboratively within a team.
• Strong organizational and communication skills.

Required skills

• Safety database systems and medical terminology.
• MedDRA coding and drug dictionary maintenance.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, and Team Share.