Drug Safety Associate I

Roles & Responsibilities
• Process Individual Case Safety Reports (ICSRs) in compliance with global pharmacovigilance regulations
• Perform case intake, triage, data entry, narrative writing, and medical coding using MedDRA and WHO-DD
• Ensure adherence to ICH-GCP, ICH-E2A/E2B, and other global regulatory guidelines
• Conduct quality checks and ensure timely submission of safety cases to regulatory authorities
• Support ongoing safety surveillance and signal detection activities
• Maintain accurate documentation and ensure inspection and audit readiness
• Collaborate with cross-functional pharmacovigilance and regulatory teams

Qualification
• B.Pharm / M.Pharm / Pharm D from a recognized institution
• Mandatory valid Pharmacy License

Experience
• Minimum 1 year of hands-on experience in pharmacovigilance or drug safety operations
• Experience in ICSR processing and global safety reporting preferred

Skills
• Strong knowledge of pharmacovigilance regulations and case processing workflows
• Hands-on experience with MedDRA and WHO-DD coding
• High attention to detail and quality mindset
• Good written and verbal communication skills
• Ability to work collaboratively in a global, compliance-driven environment
• Willingness to relocate to Bangalore or Mysore after 6 months

About the company
Qinecsa is a global life sciences and healthcare services organization specializing in pharmacovigilance, regulatory affairs, and clinical safety solutions, supporting pharmaceutical and biotech companies worldwide with high-quality, compliant, and patient-focused drug safety services while offering strong career growth opportunities in a global work environment.