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Pharmacovigilance Services Associate

Accenture
0-2 years
INR 4 LPA – 6 LPA
Bangalore, India
1 June 26, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

Pharmacovigilance Services Associate

Company: Accenture
Location: Bengaluru, India
Department: Life Sciences R&D – Pharmacovigilance Services
Job Type: Full-Time
Experience: 1–3 Years


JOB OVERVIEW

The Pharmacovigilance Services Associate supports global drug safety operations by performing Individual Case Safety Report (ICSR) processing, adverse event case management, MedDRA coding, safety database management, regulatory submissions, and follow-up activities. The role ensures compliance with global pharmacovigilance regulations while contributing to patient safety, regulatory reporting, and drug safety surveillance.


KEY RESPONSIBILITIES

ICSR Case Processing

  • Perform case identification and case intake.

  • Create and process Individual Case Safety Reports (ICSRs).

  • Enter and validate safety data in the pharmacovigilance database.

  • Perform follow-up on incomplete safety cases.

  • Ensure timely case completion within regulatory timelines.

Drug Safety Operations

  • Process adverse event reports received from various sources.

  • Perform MedDRA coding for adverse events and medical terms.

  • Maintain high-quality safety case documentation.

  • Ensure accuracy and completeness of case records.

  • Support ongoing pharmacovigilance activities.

Safety Database Management

  • Maintain and update safety databases.

  • Validate safety case information before submission.

  • Ensure data integrity and regulatory compliance.

  • Track case status throughout the lifecycle.

  • Maintain audit-ready documentation.

Regulatory Compliance

  • Follow client SOPs and global pharmacovigilance regulations.

  • Ensure compliance with ICH and GVP guidelines.

  • Support regulatory submissions and reporting.

  • Maintain inspection-ready documentation.

  • Adhere to quality and compliance standards.

Team Collaboration

  • Work closely with supervisors and pharmacovigilance teams.

  • Support daily operational activities.

  • Communicate case-related issues effectively.

  • Participate in process improvement initiatives.


EDUCATIONAL QUALIFICATIONS

Required

  • Bachelor of Pharmacy (B.Pharm)

  • Master of Pharmacy (M.Pharm)


EXPERIENCE REQUIREMENTS

Required

  • 1–3 years of experience in Pharmacovigilance, Drug Safety, or ICSR Case Processing.