Job Opportunity: Case Processing Specialist – Pharmacovigilance
Job Summary
Abbott, a global leader in the healthcare industry, is seeking two detail-oriented professionals to join our Medical & Clinical Affairs division as Case Processing Specialists in Mumbai, India. This role is designed for experienced pharmacovigilance (PV) professionals who possess a strong technical background in Individual Case Safety Report (ICSR) processing. You will play a vital role in our global drug safety operations, ensuring regulatory compliance and contributing to the integrity of our safety databases. If you are passionate about patient safety and looking to advance your career in a dynamic, international environment, we invite you to apply.
Job Overview
- Position: Case Processing Specialist
- Company: Abbott
- Location: Mumbai, India
- Department: Medical & Clinical Affairs (Pharmacovigilance)
- Employment Type: Full-Time
- Number of Openings: 2
Responsibilities
As a Case Processing Specialist, you will manage the end-to-end lifecycle of safety cases, ensuring high quality and adherence to strict regulatory guidelines. Your key responsibilities will include:
- Case Handling: Triage, prioritize, and process spontaneous and solicited ICSRs (NIODCS) throughout their full lifecycle.
- Coding & Review: Perform accurate MedDRA coding for adverse events, medications, medical history, and laboratory data. Conduct medical reviews and causality assessments.
- Data Integrity: Perform case validation, quality checks, and finalization to ensure data accuracy.
- Follow-up & Investigation: Proactively manage follow-ups with reporters to obtain missing information and investigate case amendments, deletions, or late cases.
- System & Process Support: Contribute to signal reconciliation, safety database clean-up, and assist with data migration or PV system updates.
- Compliance: Maintain and update Standard Operating Procedures (SOPs) and Work Instructions (WIs) in strict alignment with global pharmacovigilance standards, including ICH and GVP guidelines.
Requirements
We are looking for candidates who combine technical PV expertise with a commitment to high-quality output.
- Education: Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm), PharmD, Life Sciences, Biotechnology, Nursing, or an equivalent qualification.
- Experience: A minimum of 2 years of hands-on experience in ICSR case processing.
- Technical Skills:
- Demonstrated proficiency in drug safety databases (e.g., Argus, ARISg).
- In-depth knowledge of MedDRA coding conventions.
- Comprehensive understanding of global pharmacovigilance workflows and regulatory requirements (ICH, GVP, CIOMS).
- Professional Skills:
- Strong verbal and written English communication skills.
- Proficiency in Microsoft Office Suite.
- Ability to work effectively with international stakeholders.
Benefits & Career Growth
Joining the Abbott team offers more than just a job; it is a pathway to a rewarding career in global drug safety. Employees in this role will benefit from:
- Exposure to industry-leading global safety reporting systems and international regulatory environments.
- Direct experience with end-to-end ICSR processing and complex regulatory submissions.
- Opportunities to develop expertise in signal detection, risk management, and long-term pharmacovigilance strategy.
- Estimated Compensation: ₹5.5 LPA – ₹9 LPA (commensurate with experience and industry standards).
How to Apply
If you meet the requirements and are ready to contribute to our mission of improving patient health, please submit your application through the official Abbott Careers portal using the links provided below:
Abbott is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.