Pharmacovigilance Associate

Roles & Responsibilities
• Collect, review, and process Adverse Event (AE) and Serious Adverse Event (SAE) reports
• Perform case processing and data entry in safety databases such as Argus, ARISg, Oracle, or similar systems
• Conduct literature searches and review scientific publications for safety-related information
• Assist in signal detection, risk assessment, and safety trend analysis
• Ensure compliance with ICH-GCP, ICH-E2B, and applicable regulatory guidelines
• Support preparation and review of PSURs, PBRERs, and other regulatory safety documents
• Maintain accurate, complete, and audit-ready pharmacovigilance documentation
• Coordinate with Clinical, Regulatory, Quality, and other cross-functional teams
• Follow SOPs, timelines, and quality standards for safety reporting

Qualification
• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related discipline

Experience
• Freshers are eligible to apply
• Internship or academic exposure to pharmacovigilance or clinical research is an advantage

Skills
• Basic understanding of pharmacovigilance concepts and safety reporting
• Knowledge of ICH-GCP and global drug safety regulations
• Strong attention to detail and documentation skills
• Good written and verbal communication skills
• Ability to work in a team-oriented and compliance-driven environment
• Willingness to learn safety databases and PV workflows

About the Organisation
The organization is a growing healthcare and life sciences company focused on ensuring patient safety and regulatory compliance through high-quality pharmacovigilance and drug safety services, offering strong learning and career development opportunities for fresh graduates.