Sr. Process Executive - PharmacoVigilence ICSR Case Processing

2coms; Bengaluru; On-site; INR 450,000 - 650,000; Full time

Job summary

2coms in Bengaluru is seeking a Pharmacovigilance Case Processing Associate to join the growing PV team. You will handle end-to-end ICSR processing, coding and case assessment in line with SOPs and regulatory requirements.

The role emphasizes accurate data entry, timely submissions and maintaining high data quality across the case lifecycle, with opportunities to work on Argus/Veeva Safety platforms.

Qualifications

• 1-4 years of Pharmacovigilance/ICSR experience.
• Hands-on ICSR case processing experience.
• Understanding PV processes, regulatory timelines and safety lifecycle.
• Argus and/or Veeva Safety experience preferred.
• Graduate/Postgraduate in Pharmacy, Life Sciences or related field.

Responsibilities

• Manage end-to-end ICSR case processing from intake to closure.
• Perform data entry, coding and case assessment as per SOPs.
• Ensure timely submission of IC/SR within timelines and maintain data quality.
• Support QA, reconciliation and resolution of case-related queries.

Skills

ICSR processing

PV processes

Regulatory timelines

Safety case lifecycle

Communication skills

Education

Pharmacy degree

Life Sciences degree

Tools

Argus Safety

Veeva Safety

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

SPE ICSR / Pharmacovigilance

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 ICSSR 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.