Safety & Pharmacovigilance Specialist I (Hybrid, Mexico)

About the role

Syneos Health is seeking a Safety & Pharmacovigilance (PV) Specialist I to join its Clinical Solutions team in a hybrid capacity within Mexico. The role supports the processing, tracking, and reporting of Individual Case Safety Reports (ICSRs) while ensuring compliance with internal SOPs and regulatory requirements.

Key responsibilities

• Enter and track ICSR information in PVG quality and tracking systems.
• Process ICSR data according to SOPs, triage cases, and evaluate completeness and regulatory reportability.
• Code events, medical history, concomitant medications, and test results in the safety database.
• Compile narrative summaries, generate queries, and follow up until resolution.
• Support timely generation of expedited safety reports in line with applicable regulations.
• Maintain safety tracking for assigned activities and perform literature screening for safety signals.
• Conduct drug coding, maintain drug dictionaries, and perform MedDRA coding as required.
• Validate and submit xEVMPD product records, including MedDRA coding of indication terms.
• Identify and manage duplicate ICSR entries and perform quality review of ICSR data.
• Participate in SPOR/IDMP related activities.

Required profile

• Familiarity with pharmacovigilance processes and ICSR handling.
• Understanding of regulatory reporting requirements for safety data.
• Attention to detail and ability to work independently in a hybrid environment.

Required skills

• Experience with PVG quality and tracking systems.
• Proficiency in safety database entry and management.
• MedDRA coding expertise.
• Knowledge of xEVMPD product record validation and submission.
• Literature screening for safety information.
• Understanding of SPOR and IDMP activities.

What we offer

• Opportunity to work with a leading global life‑sciences services organization.
• Collaborative environment with passionate problem‑solvers.
• Career development and progression support.