2coms is hiring Pharmacovigilance professionals for multiple ICSR Case Processing roles, including Process Executive, Senior Process Executive (SPE), Subject Matter Expert (SME), and Team Leader positions.

Candidates with 1–10 years of experience in Pharmacovigilance, Drug Safety, and ICSR Case Processing can explore these opportunities. Professionals with hands-on experience in Argus Safety and/or Veeva Safety are preferred.

Job Details

About the Opportunity

2coms is recruiting experienced Pharmacovigilance and ICSR Case Processing professionals for its client, a global IT solutions organization supporting enterprise-level operations.

The available positions involve end-to-end safety case processing, including case intake, data entry, medical coding, narrative writing, case assessment, quality checks, case routing, and case closure.

This opportunity is particularly suitable for candidates with practical experience in Individual Case Safety Report (ICSR) processing, MedDRA coding, WHO Drug coding, and safety databases such as Oracle Argus Safety or Veeva Safety.

Available Pharmacovigilance Roles

1. Process Executive – ICSR Case Processing

Candidates will support the complete lifecycle of Pharmacovigilance safety cases, including:

• Book-in and case intake
• Full data entry
• Medical and product coding
• Narrative writing
• Case routing
• Self-check and quality review
• Case lock and closure
• USPI labeling
• Unblinding activities, where applicable

2. Senior Process Executive (SPE) – ICSR Case Processing

The Senior Process Executive role focuses on managing end-to-end ICSR case processing while maintaining quality, accuracy, and compliance with regulatory requirements.

Key activities include:

• ICSR intake and triage
• Data entry and case processing
• MedDRA coding
• WHO Drug coding
• Narrative writing
• Case assessment
• Follow-up activities
• Quality checks
• Query resolution
• Case closure

3. Subject Matter Expert (SME) / Team Leader

Experienced Pharmacovigilance professionals may also be considered for SME and leadership positions based on relevant experience and organizational requirements.

For Team Leader positions, relevant leadership experience may be required.

Key Responsibilities

Selected candidates will be responsible for:

• Managing end-to-end ICSR case processing
• Performing case book-in and data entry
• Conducting case intake and triage
• Writing accurate and medically relevant case narratives
• Performing MedDRA coding
• Performing WHO Drug/Product coding
• Conducting case assessment according to SOPs
• Performing self-checks using online QC tools
• Supporting case routing and workflow management
• Managing follow-up information
• Performing case lock and case closure
• Supporting USPI labeling activities
• Handling unblinding activities when required
• Maintaining accurate safety documentation
• Supporting reconciliation activities
• Resolving case-related discrepancies and queries
• Ensuring compliance with regulatory timelines
• Maintaining high standards of quality and data accuracy

Qualifications Required

Candidates should have:

• Graduate, Postgraduate, or Doctorate qualification in:
  • Pharmacy
  • Life Sciences
  • Medical Sciences
  • Other relevant healthcare disciplines
• 1–10 years of relevant Pharmacovigilance experience, depending on the role
• Experience in Drug Safety and ICSR Case Processing
• Strong understanding of the Pharmacovigilance case lifecycle
• Knowledge of serious and non-serious adverse event processing
• Understanding of regulatory timelines and compliance requirements

Required Skills

Candidates with the following skills will be preferred:

• Pharmacovigilance
• Drug Safety
• ICSR Case Processing
• Safety Case Processing
• Argus Safety
• Veeva Safety
• MedDRA Coding
• WHO Drug Coding
• Narrative Writing
• Case Assessment
• Case Processing
• Quality Review
• Quality Control
• Clinical Research
• Clinical Trials
• Regulatory Compliance
• ICH Guidelines
• Documentation
• Analytical Skills
• Communication Skills

Experience with Argus or Veeva Safety Preferred

Hands-on experience with the following safety databases is preferred:

• Oracle Argus Safety
• Veeva Safety

Candidates with practical exposure to safety databases and end-to-end ICSR processing workflows may have an advantage during the selection process.

Who Should Apply?

This Pharmacovigilance opportunity is suitable for:

• Pharmacists
• B.Pharm graduates
• M.Pharm graduates
• Pharm.D graduates
• Life Sciences graduates
• Medical Sciences professionals
• Drug Safety Associates
• Pharmacovigilance Associates
• ICSR Case Processors
• Safety Case Processing professionals
• Experienced professionals seeking SPE or SME roles

Preferred Notice Period

Candidates who are:

• Immediate joiners
• Serving a notice period
• Available within 30 days

are highly preferred.

According to the job requirements, candidates with a 90-day notice period may not be considered.

Salary and Benefits

The salary has not been officially disclosed by the employer. However, based on the role, experience, and Pharmacovigilance market standards, the expected compensation may vary approximately between:

₹4 LPA to ₹10 LPA

Actual compensation will depend on:

• Relevant Pharmacovigilance experience
• ICSR case processing expertise
• Experience with Argus Safety or Veeva Safety
• Current compensation
• Interview performance
• Role and designation

Benefits May Include

• Full-time permanent employment
• Opportunity to work in Pharmacovigilance operations
• Exposure to global Drug Safety processes
• Experience with industry-standard safety databases
• Career growth in ICSR Case Processing
• Exposure to regulatory compliance and quality processes

How to Apply?

Application Link For ICSR case processing SPE/SME

Application Link For Sr. Process Executive – PharmacoVigilance ICSR Case Processing