Sr. Process Executive - PharmacoVigilence ICSR Case Processing

2coms; Bengaluru Urban; On-site; INR 500,000 - 750,000; Full time

Job summary

2coms invites experienced Pharmacovigilance professionals for the Sr. Process Executive - ICSR Case Processing in Bangalore North, India. Join a Fortune 500 IT solutions company delivering PV services and handling end-to-end ICSR case processing.

Role focuses on intake, triage, data entry, coding with MedDRA/WHO, narrative writing, and timely submission while ensuring data quality and regulatory compliance.

Qualifications

• 1–4 years of relevant Pharmacovigilance / Drug Safety / ICSR experience.
• Hands-on experience in ICSR case processing.
• Strong understanding of PV processes, regulatory timelines and safety case lifecycle.

Responsibilities

• Manage end-to-end ICSR case processing, including intake, triage, data entry, follow-up and case closure.
• Perform MedDRA/WHO Drug coding, narrative writing and case assessment per SOPs and regulatory requirements.
• Ensure accurate and timely processing/submission of serious and non-serious ICSRs within defined timelines.
• Maintain high standards of data quality, compliance and documentation across the case lifecycle.
• Support reconciliation, quality checks and resolution of case-related queries or discrepancies.

Skills

Pharmacovigilance / Drug Safety / ICSR

ICSR case processing

PV processes

regulatory timelines

safety case lifecycle

Argus and/or Veeva Safety

Education

Graduate/Postgraduate in Pharmacy, Life Sciences, Medical Sciences

Tools

Argus

Veeva Safety

Job description

Sr. Process Executive - PharmacoVigilence ICSR Case Processing

Bangalore North, India | Posted on 09/05/2026

• Industry Pharma/Biotech/Clinical Research
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Job Description

About the Client:

Client is a global Fortune 500 IT solutions company specializing in delivering simple and scalable solutions to address complexbusiness problems. More than 1,500 staff delivers technical and domain expertise across multiple platforms and industriesto help enterprise companies drive productivity, efficiency and gain the most out of their technology investments. Designation: Pharmacovigilance – Case Processing Associate

Join our growing Pharmacovigilance team! We're looking for experienced professionals with expertise in ICSR Case Processing and Quality Review

Open Positions

Experience: 1–4 Years

Function: Pharmacovigilance / ICSR Case Processing

Key Responsibilities:

Manage end-to-end ICSR case processing, including intake, triage, data entry, follow-up and case closure.

Perform MedDRA/WHO Drug coding, narrative writing and case assessment as per SOPs and regulatory requirements.

Ensure accurate and timely processing/submission of serious and non-serious ICSPR within defined timelines.

Maintain high standards of data quality, compliance and documentation across the case lifecycle.

Support reconciliation, quality checks and resolution of case-related queries or discrepancies.

Required Skills:

1–4 years of relevant Pharmacovigilance / Drug Safety / ICSR experience.

Hands-on experience in ICSR case processing.

Strong understanding of PV processes, regulatory timelines and safety case lifecycle.

Argus and/or Veeva Safety experience preferred.

Graduate/Postgraduate in Pharmacy, Life Sciences, Medical Sciences or a related discipline.

Requirements

• Relevant educational background and experience in patient safety or related field
  
• Strong presentation and communication skills
  
• Effective intercultural work capabilities
  
• Commitment to timely completion of tasks and documentation
  
• Analytical and problem-solving skills
  
• Collaboration and teamwork abilities
  

Joining Preference: Immediate to 30 Days highly preferred. 90-day notice period candidates will not be considered.