Safety Specialist I – Hybrid (Mexico & Argentina)

About the role

As a Safety Specialist I you will support pharmacovigilance activities for our Mexico and Argentina operations in a hybrid work environment. You will ensure accurate capture, processing, and reporting of individual case safety reports (ICSRs) while adhering to internal SOPs and regulatory requirements.

Key responsibilities

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSR data.
• Process ICSR cases according to SOPs, triage for completeness, and code events, medical history, concomitant medications, and test results.
• Compile narrative summaries and manage queries until resolution.
• Generate timely 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 apply MedDRA coding.
• Validate and submit xEVMPD product records, including coding of indication terms.
• Manually recode un‑coded product and substance terms, identify and manage duplicate ICSR cases.
• Support SPOR/IDMP activities and perform quality reviews of safety data.

Required profile

• Experience with pharmacovigilance processes and ICSR handling.
• Familiarity with SOP‑driven safety workflows and regulatory reporting.

Required skills

• PVG quality and tracking systems
• ICSR processing and triage
• MedDRA coding
• Drug coding and dictionary maintenance
• xEVMPD validation and submission
• SPOR/IDMP activities