Pharmacovigilance Associate

Job Description:

Responsibilities

• Collect, assess, and process adverse event reports to ensure accuracy and timely compliance with regulatory requirements
• Partner with cross-functional teams to address safety-related questions and support ongoing investigations
• Maintain current knowledge of pharmacovigilance regulations, global safety guidelines, and industry standards
• Manage safety inbox and acknowledge case receipt.
• Perform case triage and book-in to safety database.
• Enter case details accurately and write narratives.
• Code events, drugs, and medical history using MedDRA/WHO-DD.
• Apply correct product labeling and perform QC checks.
• Finalize case processing and generate queries for follow-up
• Knowledge of seriousness, expectedness, causality, and global reporting
• Familiarity with reconciliation processes and aggregate reporting (PSUR/DSUR)
• Ability to mentor new joiners and review SOPs
• Working knowledge of SDEA and KPI/SLA basics
• Process literature ICSRs and maintain compliance with monitoring requirements

Qualification & Experience

• Minimum 2 years of experience in safety background, with direct involvement in case processing
• Solid experience in Post Marketing Surveillance/Clinical Trial case processing
• Bachelors degree in life sciences
• Strong analytical skills with attention to detail in data collection and reporting
• Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders
• A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities