Safety & PV Specialist I – Mexico Remote

About the role

Syneos Health is seeking a Safety & Pharmacovigilance (PV) Specialist I to work remotely from Mexico. The role supports the Clinical Solutions team by processing safety data, ensuring regulatory compliance, and contributing to timely adverse event reporting.

Key responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking of Individual Case Safety Reports (ICSRs).
• Process and triage ICSR data according to Standard Operating Procedures and project‑specific safety plans.
• Code events, medical history, concomitant medications, and laboratory tests using MedDRA.
• Compile complete narrative summaries and manage queries until resolution.
• Generate expedited safety reports in line with applicable regulatory requirements.
• Maintain safety tracking for assigned activities and perform literature screening for safety signals.
• Validate and submit xEVMPD product records, including coding of indication terms.
• Identify and manage duplicate ICSR entries and perform manual recoding of un‑coded product terms.
• Support activities related to SPOR/IDMP and conduct quality reviews of ICSR data.

Required profile

• Familiarity with pharmacovigilance processes and regulatory reporting requirements.
• Ability to follow SOPs and adhere to project‑specific safety plans.
• Attention to detail for accurate data entry and coding.
• Strong organizational skills to manage queries and tracking activities.

Required skills

• Pharmacovigilance (PV) systems and safety database usage.
• ICSR processing and triage.
• MedDRA coding.
• xEVMPD product record validation and submission.
• Literature screening for safety.
• Regulatory reporting of expedited safety reports.

What we offer

• Opportunity to work with a leading global life‑sciences services organization.
• Remote work flexibility from Mexico.
• Professional development within a collaborative, inclusive culture.