Safety & Pharmacovigilance Specialist I (Hybrid, Mexico)

About the role

The Safety & Pharmacovigilance Specialist I will support the Clinical Solutions team by managing safety case information and ensuring regulatory compliance. This hybrid position is based in Mexico and works closely with global pharmacovigilance processes.

Key responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking of Individual Case Safety Reports (ICSRs).
• Assist in processing ICSR data according to Standard Operating Procedures and project‑specific safety plans.
• Tri­age ICSR submissions, evaluate completeness, accuracy, and regulatory reportability.
• Code events, medical history, concomitant medications, and test results in the safety database.
• Compile complete narrative summaries and generate queries to obtain missing information.
• Support timely and accurate generation of expedited safety reports in line with regulatory requirements.
• Maintain safety tracking for assigned activities and perform literature screening for safety signals.
• Conduct drug coding, maintain drug dictionaries, and apply MedDRA coding as required.
• Validate and submit xEVMPD product records, including coding of indication terms using MedDRA.
• Manually recode un‑coded product and substance terms, identify and manage duplicate ICSR entries.
• Perform activities related to SPOR/IDMP and conduct quality review of ICSR data.

Required profile

Required skills

• MedDRA coding
• xEVMPD product record submission
• IDMP and SPOR processes
• Pharmacovigilance database entry and coding