Case Processing Specialist
Company: Abbott
Location: Mumbai, India
Job Type: Full-Time
Experience: Typically 2+ Years (ICSR Processing / Pharmacovigilance)
Qualification: Degree in Life Sciences, Nursing, Information Management or equivalent
Salary Range: Not Specified
Job Overview
Abbott is hiring a Case Processing Specialist responsible for end-to-end processing of Individual Case Safety Reports (ICSRs) for pharmacovigilance activities.
The role involves triaging, processing, medical review, and coding of adverse event cases received from multiple sources including spontaneous reports, non-interventional studies, literature, and regulatory authorities. The specialist ensures compliance with global regulations, internal SOPs, and timelines while maintaining high-quality safety data.
Key Responsibilities
Case Processing & Management
Perform full case processing of spontaneous and solicited ICSRs.
Handle cases from NIODCS, literature, regulatory authorities, and partner sources.
Ensure timely processing in line with regulatory requirements and SOPs.
Case Triage & Prioritization
Prioritize incoming ICSRs based on regulatory timelines and requirements.
Manage workload efficiently to meet global reporting standards.
Medical Review & Causality Assessment
Perform medical review for selected cases.
Determine company causality for solicited ICSRs where applicable.
Ensure clinical accuracy and completeness of case data.
Coding & Data Entry
Code adverse events, medications, medical history, and lab data using MedDRA conventions.
Ensure accurate and consistent coding of safety data.
Case Verification & Follow-up
Verify case data and finalize case versions.
Initiate follow-up queries and obtain missing information.
Handle case amendments, deletions, and updates.
Quality & Compliance
Ensure adherence to global pharmacovigilance regulations and internal SOPs/WIs.
Support case data reconciliation and data clean-up activities.
Assist in late case investigations and CAPA recommendations.
System & Process Support
Support safety database updates and data migration activities.
Assist in maintaining and updating SOPs and work instructions.
Collaborate on process improvement initiatives.
Required Skills
Pharmacovigilance Expertise
Strong understanding of ICSR processing and safety reporting.
Knowledge of MedDRA coding conventions.
Understanding of pharmacovigilance regulations and workflows.
Technical Skills
Experience with drug safety databases.
Proficiency in Microsoft Office tools.
Familiarity with case processing systems and workflows.
Analytical Skills
Attention to detail and data accuracy.
Ability to analyze and verify clinical safety data.
Communication
Good command of English (written and verbal).
Ability to communicate with cross-functional teams.
Operational Skills
Ability to manage timelines and prioritize workload.
Capability to work under supervision while ensuring quality outputs.
Basic Qualifications
Degree in life sciences, nursing, information management or equivalent
Minimum 2 years of experience in ICSR processing
Experience with pharmacovigilance systems and medical coding
Preferred Competencies
Experience with drug safety databases
Knowledge of regulatory requirements and safety processes
Training in pharmacovigilance systems and workflows
Key Competencies
ICSR case processing and safety data management
Medical review and causality assessment
Pharmacovigilance compliance and reporting
Data coding and verification
Quality and process adherence
About the Company
Abbott is a global healthcare company focused on developing innovative products and technologies across diagnostics, medical devices, nutrition, and pharmaceuticals. The company is committed to improving health outcomes through science-based solutions and operates in over 160 countries worldwide.
Uttar Pradesh :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Galway |County Dublin :
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Queensland |Melbourne :
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Canada |Quebec :
Montreal |Brussels :
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Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Croatia |Zagreb :
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