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Pharmacovigilance Services New Associate

Accenture
0-1 years
INR 3.5 LPA – 5.5 LPA
Bangalore, India
1 July 1, 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 New Associate

Company: Accenture
Location: Bengaluru, India
Department: Life Sciences R&D – Pharmacovigilance Services
Job Type: Full-Time
Experience: 0–1 Year

JOB OVERVIEW

The Pharmacovigilance Services New Associate is responsible for supporting global drug safety operations by processing Individual Case Safety Reports (ICSRs), performing data entry, MedDRA coding, case processing, and follow-up activities in accordance with global regulatory requirements and client guidelines. The role involves monitoring adverse events, maintaining safety databases, ensuring data quality, and contributing to pharmacovigilance activities that help ensure patient safety and regulatory compliance.


KEY RESPONSIBILITIES

ICSR Case Processing

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

  • Perform case intake and initial case assessment.

  • Review source documents for reportable safety information.

  • Process adverse event reports according to client procedures.

  • Ensure timely completion of safety cases.

Safety Data Entry

  • Enter safety data into pharmacovigilance databases.

  • Record patient, product, and adverse event information accurately.

  • Maintain complete and accurate case documentation.

  • Update case information throughout the processing lifecycle.

  • Ensure compliance with client SOPs and regulatory requirements.

MedDRA Coding

  • Perform MedDRA coding for adverse events.

  • Code medical history and concomitant medications.

  • Ensure accurate and consistent medical terminology coding.

  • Follow global coding standards and client guidelines.

  • Review coding accuracy before case completion.

Adverse Event Management

  • Review and evaluate adverse event reports.

  • Support case processing and safety surveillance activities.

  • Assist in identifying reportable safety events.

  • Escalate potential safety concerns when required.

  • Contribute to patient safety monitoring.

Case Follow-up

  • Initiate follow-up requests for incomplete cases.

  • Track pending follow-up information.

  • Update safety cases with additional information received.

  • Maintain follow-up communication records.

  • Ensure case completeness before closure.

Quality Assurance

  • Perform quality checks on processed cases.

  • Ensure data accuracy and completeness.

  • Correct discrepancies identified during review.

  • Follow quality standards and client procedures.

  • Maintain productivity and quality targets.

Regulatory Compliance

  • Follow global pharmacovigilance regulations.

  • Adhere to client SOPs and regulatory guidelines.

  • Support compliance with reporting timelines.

  • Maintain inspection-ready documentation.

  • Participate in continuous learning and training activities.


EDUCATIONAL QUALIFICATIONS

Required

  • Bachelor of Pharmacy (B.Pharm)


EXPERIENCE REQUIREMENTS

Required

  • 0–1 year of Pharmacovigilance or Drug Safety experience

Freshers Welcome

  • Recent B.Pharm graduates are encouraged to apply.