Drug Safety Associate

Tata Consultancy Services; Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

Tata Consultancy Services in Mumbai is seeking a Pharmacovigilance/Drug Safety Associate with 2–6 years of experience to manage case handling in line with client SOPs, focusing on quality review and timely processing in Argus Safety.

You will document cases, participate in audits and oversight meetings, and act as SME for QA processes, contributing to continuous improvements while maintaining strong stakeholder communication.

Qualifications

• 2–6 years of experience in Pharmacovigilance/Drug Safety.
• Hands-on experience with Argus Safety database.
• Strong knowledge of ICSR processing and case quality review.
• Good understanding of pharmacovigilance regulations and SOPs.
• Excellent communication and stakeholder management skills.

Responsibilities

• Perform case selection and allocation as per client SOP and WIs.
• Conduct quality review of valid and invalid cases within defined SLAs.
• Document cases in SMOCQA tool.
• Analyze and review refuted errors.
• Attend internal, client, and vendor oversight meetings.
• Participate in audits as SME for QA processes.
• Perform additional tasks assigned by the supervisor.

Skills

Argus Safety

Drug Safety/Pharmacovigilance

ICSR Processing

Job description

Job Description – Pharmacovigilance / Drug Safety Associate

Experience: 2-6 Years

Walk-In Drive: 11th September

Mandatory Skills

• Argus Safety
• Drug Safety / Pharmacovigilance
• ICSR (Individual Case Safety Report) Processing

Key Responsibilities

• Perform case selection and allocation as per client SOP and WIs.
• Conduct quality review of valid and invalid cases within defined SLAs.
• Document cases in SMOCQA tool.
• Analyze and review refuted errors.
• Attend internal, client, and vendor oversight meetings.
• Participate in audits as Subject Matter Expert (SME) for Quality Review processes.
• Perform additional tasks assigned by the supervisor.

Required Experience

• 2-6 years of experience in Pharmacovigilance/Drug Safety.
• Hands-on experience in Argus Safety database.
• Strong knowledge of ICSR processing and case quality review.
• Good understanding of pharmacovigilance regulations and SOPs.
• Excellent communication and stakeholder management skills.