Drug Safety Associate – Pharmacovigilance / ICSR Processing
Company: Infomerica
Locations: Kochi, Thane, Bengaluru | India
Employment Type: Full-Time | Permanent | Openings: 5
Build Your Career in Pharmacovigilance and Drug Safety
Join a dynamic healthcare and life sciences team supporting global drug safety operations and pharmacovigilance processes. This opportunity is designed for professionals with experience in Individual Case Safety Report (ICSR) processing and safety database management who are looking to grow their careers in clinical safety and regulatory compliance.
Job Overview
The Drug Safety Associate is responsible for supporting pharmacovigilance activities, including case intake, safety data processing, adverse event reporting, and regulatory compliance. The role involves evaluating adverse event reports, performing medical coding, ensuring case completeness, and managing safety data within industry-standard databases.
The position requires strong knowledge of drug safety processes, regulatory timelines, and pharmacovigilance systems to ensure high-quality case processing and patient safety monitoring.
Key Responsibilities
Receive and process adverse event reports from healthcare professionals, patients, literature sources, and call centers.
Validate case reports based on minimum reporting criteria, including identifiable patient, reporter, suspect drug, and adverse event.
Perform accurate data entry into safety databases such as Argus Safety, ArisG, Veeva, or similar systems.
Follow up with relevant stakeholders to obtain missing or incomplete safety information.
Ensure compliance with reporting timelines and regulatory requirements.
Perform medical coding using MedDRA terminology.
Assess case seriousness, expectedness, and causality in accordance with company standard operating procedures.
Identify duplicate case reports and maintain data accuracy.
Ensure case completeness and quality prior to submission for medical review.
Support pharmacovigilance operations and safety monitoring activities.
Required Qualifications and Experience
Bachelor of Pharmacy (B.Pharm) or equivalent degree in a relevant life sciences discipline.
Minimum 1 to 5 years of experience in drug safety, pharmacovigilance, or ICSR case processing.
Hands-on experience with Individual Case Safety Reports (ICSR) and safety database systems such as Argus Safety or equivalent platforms.
Knowledge of pharmacovigilance processes, adverse event reporting, and regulatory requirements.
Familiarity with MedDRA coding and clinical safety data management.
Strong analytical and attention-to-detail skills.
Ability to manage multiple cases and meet strict reporting timelines.
Preferred Skills
Experience in case processing and safety data review workflows.
Knowledge of global pharmacovigilance guidelines and regulatory frameworks.
Strong communication and documentation skills.
Ability to work in a collaborative and fast-paced healthcare environment.
Compensation and Benefits
Salary range: INR 2–4 LPA (including performance-based variable component).
Opportunity to work in global pharmacovigilance and healthcare projects.
Career growth in clinical safety and regulatory operations.
About the Organization
Infomerica is a technology and consulting organization providing digital transformation, cloud solutions, and enterprise technology services. The company supports business innovation through data analytics, system integration, and technology-driven healthcare and life sciences solutions, serving global clients across multiple industries.
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