Safety Specialist I (Hybrid) – Mexico & Argentina

About the role

Syneos Health is seeking a Safety Specialist I to support pharmacovigilance activities for its Mexico and Argentina operations. This hybrid position combines remote work with occasional onsite collaboration, ensuring timely processing of safety data and regulatory reporting.

Key responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSR.
• Assist in processing ICSR according to SOPs and project‑specific safety plans.
• Tri­age ICSR, evaluate data for completeness, accuracy and regulatory reportability.
• Code events, medical history, concomitant medications and tests; compile narrative summaries.
• Identify and follow up on queries to obtain missing information.
• Generate expedited reports in line with regulatory requirements.
• Perform literature screening, maintain drug dictionaries and MedDRA coding.
• Validate and submit xEVMPD product records, including MedDRA indication coding.
• Manage duplicate ICSR, conduct quality review and ensure documentation is filed in TMF and PS Master File.

Required profile

• Familiarity with pharmacovigilance processes and regulatory guidelines.
• Experience handling ICSR data and safety database entry.
• Knowledge of MedDRA coding and drug dictionary maintenance.
• Understanding of xEVMPD, SPOR and IDMP requirements.
• Ability to work accurately in a hybrid environment.

Required skills

• MedDRA coding
• Pharmacovigilance database entry
• xEVMPD product record validation
• IDMP/SPOR processes

What we offer

• Career development within a global biopharmaceutical organization.
• Supportive line management and total rewards program.
• Inclusive Total Self culture promoting authenticity.