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Senior Pharmacovigilance Associate

ICON Strategic Solutions · Mexique

Senior 🇬🇧 English
Pharmacovigilance databases Data management systems Microsoft Office Suite

Job description

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 clinical development of pharmaceutical products.

Key responsibilities

  • Lead collection, evaluation, and processing of adverse event reports in line with regulatory guidelines.
  • Analyze safety data, identify trends and potential safety signals for further investigation.
  • 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.
  • Maintain pharmacovigilance databases, ensuring data integrity and compliance.
  • Provide training and mentorship to junior team members on PV processes and regulations.
  • Support audits and inspections by regulatory authorities, ensuring readiness and compliance.

Required profile

  • Bachelor’s degree in a scientific or healthcare‑related discipline.
  • Extensive experience in pharmacovigilance or drug safety, with strong knowledge of relevant regulations.
  • Proven ability to manage adverse event reporting and signal detection independently.
  • Strong analytical, critical‑thinking and communication skills.
  • Willingness to travel up to 15% as required.

Required skills

  • Proficiency with pharmacovigilance databases and data‑management systems.
  • Advanced use of Microsoft Office Suite.

What we offer

  • Competitive salary and a comprehensive benefits package.
  • Inclusive, diverse culture that rewards high performance.
  • Opportunities for professional growth within a global healthcare intelligence organization.

Questions fréquentes

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Published 3 months ago

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ICON Strategic Solutions

Mexique