2COMS is hiring experienced Pharmacovigilance professionals for ICSR Case Processing SPE/SME roles for its client, a leading global Fortune 500 IT solutions organization. The openings are available in Hyderabad, Pune, Mumbai, and Bengaluru and are suitable for candidates with hands-on experience in pharmacovigilance safety case processing.

Candidates with a Graduate, Postgraduate, or Doctorate qualification in Life Sciences, Pharmacy, Medical Sciences, or an equivalent discipline can apply. Applicants should have relevant experience in ICSR case processing and practical exposure to Veeva Safety and/or Oracle Argus Safety.

The position involves end-to-end safety case processing activities, including case book-in, data entry, narrative writing, MedDRA/medical coding, product coding, quality checks, case routing, labeling assessment, and case closure.

Job Overview

Key Responsibilities

Selected candidates for the ICSR Case Processing SPE/SME jobs will support pharmacovigilance operations and perform activities such as:

• Perform case book-in and complete safety case data entry.
• Process Individual Case Safety Reports (ICSRs) according to applicable procedures.
• Prepare accurate and medically consistent case narratives.
• Perform medical coding and product coding.
• Conduct self-quality checks using an online QC tool.
• Review safety case information for accuracy and completeness.
• Perform unblinding activities when required and permitted by applicable procedures.
• Route cases through the appropriate pharmacovigilance workflow.
• Perform case lock and closure activities where applicable.
• Support USPI labeling assessments.
• Maintain accurate and timely pharmacovigilance documentation.
• Meet established case-processing timelines and quality requirements.
• Collaborate effectively with safety teams and other stakeholders.

Eligibility & Qualifications

Candidates interested in these Pharmacovigilance ICSR Case Processing jobs should meet the following criteria:

Educational Qualification:

Graduate, Postgraduate, or Doctorate in:

• Pharmacy
• Life Sciences
• Medical Sciences
• Or an equivalent/relevant discipline

Experience:

Applicants should have approximately 1–10 years of Pharmacovigilance Safety Case Processing experience. Team Leader positions require relevant leadership experience, with the supplied job description specifically mentioning two years of on-paper TL experience.

Database Experience:

Hands-on experience with at least one of the following safety databases is expected:

• Veeva Safety
• Oracle Argus Safety

Key Skills Required

Candidates should have working knowledge or experience in:

• ICSR Case Processing
• Pharmacovigilance
• Drug Safety
• Safety Case Data Entry
• Case Book-in
• Narrative Writing
• MedDRA / Medical Coding
• Product Coding
• Argus Safety
• Veeva Safety
• Case Quality Control
• Case Routing
• Case Lock and Closure
• USPI Labeling
• Clinical Research
• Safety Documentation
• Analytical and Problem-Solving Skills
• English Communication
• Cross-functional Collaboration

Who Should Apply?

This opportunity is particularly relevant for pharmacovigilance professionals currently working as Drug Safety Associates, Pharmacovigilance Associates, Safety Case Processors, Process Executives, Senior Process Executives, PV SMEs, ICSR Specialists, or Team Leaders.

Candidates with hands-on end-to-end ICSR processing experience and practical knowledge of Argus Safety or Veeva Safety may be particularly aligned with the requirements.

This is not advertised as a fresher position. The supplied job description asks for at least one year of relevant pharmacovigilance safety case processing experience.

Why Consider This Opportunity?

This recruitment provides experienced pharmacovigilance professionals an opportunity to work on core ICSR case processing and drug safety operations.

Potential professional advantages include:

• Exposure to end-to-end pharmacovigilance case processing.
• Opportunity to work with widely used safety databases such as Argus Safety and Veeva Safety.
• Experience in narrative writing, medical coding, labeling, QC and case closure.
• Opportunities across multiple major Indian pharmaceutical and technology hubs.
• Career relevance for professionals seeking progression within pharmacovigilance and patient safety operations.

Benefits, compensation, incentives, insurance, leave policies and other employee benefits should be confirmed directly with the recruiter or employer, as these details were not specified in the supplied job advertisement.

How to Apply

Application Link