Safety & Pharmacovigilance Specialist I (Remote, Mexico)

About the role

Syneos Health is seeking a Safety & PV Specialist I to support pharmacovigilance activities on a remote basis from Mexico. You will work within the Clinical Solutions team, ensuring accurate processing and reporting of adverse event information in compliance with regulatory standards.

Key responsibilities

• Enter and track ICSR data in PVG quality and tracking systems.
• Process ICSR cases according to SOPs and project‑specific safety plans.
• Tri­age cases, evaluate completeness, code events, medical history, concomitant medications, and test results.
• Compile narrative summaries and manage queries until resolution.
• Generate timely expedited reports in line with regulatory requirements.
• Maintain safety tracking for assigned activities and perform literature screening.
• Conduct drug coding, MedDRA coding, and maintain the drug dictionary.
• Validate and submit xEVMPD product records, including indication coding.
• Manually recode un‑coded product terms, identify duplicate ICSR cases, and support SPOR/IDMP activities.
• Perform quality review of ICSR documentation.

Required profile

• Experience with ICSR processing and safety database entry.
• Familiarity with pharmacovigilance SOPs and regulatory reporting timelines.
• Ability to conduct literature reviews and manage data quality.

Required skills

• MedDRA coding
• xEVMPD submission
• SPOR/IDMP knowledge
• Pharmacovigilance database management

What we offer

• Career development and progression opportunities.
• Supportive line management and technical training.
• Inclusive culture focused on delivering impact for patients.