Senior Pharmacovigilance Associate

About the role

ICON plc is seeking a Senior Pharmacovigilance Associate to work remotely from Mexico City. In this role you will lead safety monitoring activities, ensure regulatory compliance, and support the delivery of high‑quality clinical research outcomes.

Key responsibilities

• Lead the collection, evaluation, and processing of adverse event reports in line with regulatory guidelines.
• Analyze safety data, identify trends and potential safety signals, and prepare investigative reports.
• Prepare and submit periodic safety update reports (PSURs) and other regulatory documents.
• Collaborate with medical and clinical teams to assess clinical relevance of adverse events and contribute to risk‑management plans.
• Maintain the integrity of pharmacovigilance databases and ensure data‑management standards are met.
• Provide training and mentorship to junior team members on pharmacovigilance processes.
• Support audits and inspections by regulatory authorities, ensuring readiness and compliance.
• Stay updated on evolving regulatory guidelines and industry best practices.

Required profile

• Bachelor’s degree in life sciences, pharmacy, nursing or a related field (advanced degree preferred).
• Extensive experience in pharmacovigilance or drug safety with strong knowledge of relevant regulations.
• Proven ability to manage adverse event reporting and signal detection processes.
• Strong analytical, critical‑thinking and communication skills.
• Ability to work independently, manage multiple priorities and maintain confidentiality.

Required skills

• Pharmacovigilance databases
• Data management systems
• Microsoft Office Suite