Pharmacovigilance Associate

Why This Role Matters

Pharmacovigilance plays a critical role in protecting patient safety by monitoring, detecting, and preventing adverse drug reactions. As a Pharmacovigilance Associate at Tata Consultancy Services, you will contribute directly to global drug safety operations, ensuring regulatory compliance and supporting pharmaceutical clients in maintaining high-quality safety standards. This role is essential in strengthening patient trust, maintaining regulatory integrity, and supporting life sciences innovation through structured safety monitoring and reporting.

Job Description

Tata Consultancy Services is hiring Pharmacovigilance Associates to support adverse event case processing, safety data management, and regulatory compliance activities. The selected candidate will be responsible for reviewing and processing Individual Case Safety Reports (ICSRs), performing drug safety data entry and validation, and ensuring accurate and timely submission of regulatory reports. The role requires hands-on experience with safety databases such as Argus or ARISg and strong knowledge of global pharmacovigilance regulations.

Key Features of the Role:

• Exposure to global pharmacovigilance operations
• Opportunity to work with leading pharmaceutical clients
• Hands-on experience with Argus Safety and ARISg databases
• Involvement in signal detection and risk assessment support
• Cross-functional collaboration within life sciences teams
• Competitive salary structure aligned with industry standards

Responsibilities

• Process and review adverse event case reports
• Perform drug safety data entry and validation
• Ensure compliance with global pharmacovigilance regulations
• Work on safety databases such as Argus or ARISg
• Conduct case follow-ups and resolve safety queries
• Prepare and review case narratives
• Maintain accuracy and completeness of safety data
• Collaborate with cross-functional teams for safety reporting
• Support signal detection and risk assessment activities
• Participate in audits and regulatory inspections
• Maintain documentation as per SOPs and guidelines
• Ensure timely submission of regulatory reports
• Identify discrepancies and resolve safety data issues
• Assist in quality control and compliance checks

Required Qualifications

• University Graduate (Life Sciences, Pharmacy, Biotechnology, Nursing, or related field preferred)
• 2–4 years of experience in pharmacovigilance or drug safety
• Experience in ICSR processing and case management
• Hands-on knowledge of Argus Safety or ARISg

Educational Requirements:

• Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, or related discipline
• Relevant certification in Pharmacovigilance preferred

Experience and Skills:

• Strong understanding of pharmacovigilance and drug safety processes
• Expertise in ICSR case processing
• Knowledge of global regulatory compliance requirements
• Proficiency in Argus Safety or ARISg
• Good understanding of medical terminology
• Strong analytical and data review skills
• Attention to detail and quality-focused mindset
• Effective communication and documentation skills
• Ability to work within defined timelines and SOP frameworks

Age Eligibility:

No specific age criteria mentioned. Candidates must meet educational and experience requirements.

Salary Insights

₹4,00,000 – ₹8,00,000 per annum (based on experience and expertise). Compensation may vary depending on candidate profile, project allocation, and skill level.

Company Overview

Tata Consultancy Services (TCS) is a global IT services, consulting, and business solutions organization delivering technology-driven solutions to leading enterprises worldwide. With a strong presence in life sciences and healthcare domains, TCS supports pharmaceutical and biotech organizations in pharmacovigilance, regulatory operations, clinical research, and digital transformation initiatives. TCS operates across multiple countries and is known for innovation, operational excellence, and client-centric solutions.

FAQs

1. Is experience in Argus mandatory?
Experience in Argus or ARISg is strongly preferred.

2. Is this a client-facing role?
The role involves collaboration with internal and external stakeholders in safety reporting.

3. Is remote work available?
Location is specified as Mumbai / Pune; work model depends on project allocation.

4. What growth opportunities are available?
Career progression may include Senior PV Associate, Drug Safety Specialist, or Quality Reviewer roles.

Application Tips

• Highlight ICSR processing and case narrative experience clearly
• Mention safety database expertise (Argus/ARISg) prominently
• Showcase knowledge of global PV regulations
• Quantify case volume handled per month if possible
• Emphasize audit experience and compliance adherence
• Tailor your CV specifically for pharmacovigilance keywords