Drug Safety Associate

Roles & Responsibilities:
• Perform end-to-end ICSR processing and case validation
• Receive and review adverse event reports from HCPs, patients, literature, and call centers
• Validate cases as per minimum reporting criteria
• Enter and manage data in safety databases (Argus, ARISg, Veeva Safety, etc.)
• Conduct duplicate checks and follow up for missing safety information
• Perform MedDRA coding for adverse events
• Assess seriousness, expectedness, and causality as per SOPs
• Ensure compliance with global regulatory timelines
• Submit cases for medical review and maintain proper documentation

Qualification:
• Bachelor of Pharmacy (mandatory)

Experience:
• Minimum 1+ year of experience in Drug Safety / Pharmacovigilance
• Hands-on experience in ICSR processing
• Practical exposure to Argus Safety

Skills:
• Strong knowledge of pharmacovigilance workflows and ICSR lifecycle
• Expertise in MedDRA coding and safety database systems
• Understanding of global PV guidelines and regulatory timelines
• Attention to detail and strong documentation skills

About the Organization:
Infomerica is a leading staffing consultancy specializing in IT and healthcare recruitment. The company connects skilled professionals with global organizations, supporting structured and compliance-driven pharmacovigilance operations.