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Global healthcare leader Abbott is hiring for Case Processing Specialist roles in Mumbai, India under the Medical & Clinical Affairs division. This opportunity is ideal for pharmacovigilance (PV) professionals with ICSR processing experience who want to work in a global drug safety environment.
If you have hands-on experience in ICSR case processing, MedDRA coding, and safety databases, this role offers strong exposure to global pharmacovigilance operations and regulatory compliance.
๐ Job Overview
- Position: Case Processing Specialist
- Company: Abbott
- Location: Mumbai, India
- Department: Medical & Clinical Affairs (Pharmacovigilance)
- Openings: 2 Roles
- Experience Required: Minimum 2 years (ICSR Processing)
- Job Type: Full-Time
๐งช Key Responsibilities (Pharmacovigilance / ICSR Processing)
The Case Processing Specialist will be responsible for end-to-end ICSR case handling and pharmacovigilance activities, including:
- Triage and prioritization of Individual Case Safety Reports (ICSRs)
- Full lifecycle case processing of spontaneous and solicited ICSRs (NIODCS)
- Perform medical review and causality assessment
- MedDRA coding for adverse events, drugs, medical history, lab data
- Case validation, quality checks, and finalization
- Follow-up with reporters for missing information
- Handle case amendments, deletions, and late case investigations
- Support signal reconciliation and safety database clean-up activities
- Participate in data migration and PV system updates
- Maintain and update SOPs and Work Instructions (WIs)
๐ Strong focus on global pharmacovigilance compliance (ICH, GVP guidelines)
๐ Eligibility Criteria
Education:
- B.Pharm / M.Pharm / PharmD
- Life Sciences / Nursing / Biotechnology / Equivalent
Experience:
- Minimum 2+ years in ICSR case processing
- Experience in drug safety databases (Argus, ARISg, etc.) preferred
- Knowledge of MedDRA coding conventions
Skills Required:
- Strong understanding of pharmacovigilance workflows
- Regulatory knowledge (ICH, GVP, CIOMS)
- Good command of English communication
- Proficiency in Microsoft Office tools
๐ผ Why This Role is Important (PV Career Growth)
This Abbott pharmacovigilance job in Mumbai provides:
- Exposure to global safety reporting systems
- Hands-on work with ICSR processing and regulatory submissions
- Opportunity to work with international stakeholders and safety databases
- Career growth in drug safety, signal detection, and risk management
๐ฐ Salary Insight (Estimated)
- โน5.5 LPA โ โน9 LPA (Expected Range)
(Based on industry standards for 2โ5 years PV experience in India)
๐ How to Apply
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