Case Processing Specialist – Pharmacovigilance / Drug Safety
Location: Mumbai, India
Department: Medical and Clinical Affairs
Employment Type: Full-Time
Experience Required: Minimum 2–4 years in ICSR case processing or pharmacovigilance
Job Overview
We are seeking a detail-oriented Case Processing Specialist with strong expertise in pharmacovigilance and drug safety operations. The role focuses on end-to-end processing of Individual Case Safety Reports (ICSRs), ensuring compliance with global regulatory requirements and internal standard operating procedures. This position is ideal for professionals looking to advance their careers in global drug safety and regulatory compliance within a structured and high-impact environment.
Key Responsibilities
Manage triage and prioritization of ICSRs received from multiple sources including spontaneous reports, literature, regulatory authorities, investigator-initiated studies, and licensing partners
Perform complete case processing of both spontaneous and solicited ICSRs from non-interventional organized data collection schemes within defined timelines
Conduct medical review and assess company causality for applicable cases
Execute accurate coding of adverse events, indications, medical history, laboratory data, and medications using MedDRA conventions
Validate and verify case data to ensure quality and completeness before final submission
Initiate and manage case follow-ups, including drafting queries and obtaining clarifications
Handle case amendments, deletions, and updates as per regulatory and internal requirements
Support late case investigations and recommend corrective and preventive actions (CAPA)
Assist in reconciliation, data cleanup, and database quality improvement activities
Contribute to safety database updates, data migration, and process improvement projects
Support the maintenance and updating of pharmacovigilance documentation including SOPs and work instructions
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field
Strong understanding of pharmacovigilance principles and global drug safety regulations
Good command of English, both written and verbal
Proficiency in Microsoft Office tools
Preferred Skills and Experience
Minimum 2+ years of hands-on experience in ICSR case processing
Experience working with drug safety databases such as Argus, ArisG, or similar systems
Familiarity with MedDRA coding and regulatory reporting requirements
Strong analytical, problem-solving, and organizational skills
Ability to manage multiple priorities and meet strict timelines
Experience with quality systems, audits, and compliance frameworks is an advantage
Role Scope and Work Environment
This role involves working under structured supervision while contributing to critical pharmacovigilance operations. The candidate will play a key role in ensuring data accuracy, regulatory compliance, and patient safety across global markets.
Why Apply
This opportunity offers exposure to global pharmacovigilance processes, advanced safety systems, and regulatory environments, making it an excellent role for professionals aiming to build a strong career in drug safety and clinical risk management.
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