Job Summary

The Vigilance Reporting Associate is responsible for supporting global adverse event reporting and product complaint handling. This role ensures timely, accurate, and compliant processing of safety data in alignment with international regulatory requirements.

This is an excellent opportunity for healthcare, nursing, pharmacy, or life sciences professionals who want to transition into the pharmacovigilance / drug safety industry.

Key Responsibilities

• Receive, review, and process adverse event and product complaint reports
• Perform accurate case intake, data entry, and documentation in safety databases
• Conduct initial case assessment, classification, and triage
• Support preparation of regulatory safety reports (ICSRs / MDRs where applicable)
• Ensure compliance with global pharmacovigilance regulations (FDA, EMA, ICH guidelines)
• Coordinate case follow-ups with QA, Regulatory, Medical, and Clinical teams
• Maintain data integrity, quality standards, and audit readiness
• Support continuous improvement of safety reporting processes

Qualifications

Required:

• Bachelor’s degree in Nursing, Pharmacy, Life Sciences, or related healthcare field
• Clinical or bedside hospital experience (preferred or required depending on project)
• Strong communication and documentation skills
• Ability to work in a regulated, detail-oriented environment

Preferred:

• Experience in pharmacovigilance, drug safety, or clinical research
• Exposure to medical device complaints or safety reporting systems
• Familiarity with medical terminology and healthcare workflows