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Pharmacovigilance Services Analyst

Accenture
3-5 years
Not Disclosed
Bangalore, India
1 June 2, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Pharmacovigilance Services Analyst (Senior Drug Safety Associate)

Location: Bengaluru, India
Employment Type: Full-Time
Department: Pharmacovigilance Operations / Drug Safety
Experience: 3–5 Years
Qualification: B.Pharm / M.Pharm

Position Overview

We are seeking a detail-oriented Pharmacovigilance Services Analyst to support global drug safety and pharmacovigilance operations. The role involves end-to-end processing of Individual Case Safety Reports (ICSRs), including case intake, data entry, MedDRA coding, medical review support, case processing, regulatory submissions, and follow-up activities in compliance with global regulatory requirements and client-specific procedures.

The successful candidate will contribute to ensuring patient safety, regulatory compliance, and high-quality pharmacovigilance deliverables while working within a dynamic Life Sciences and Drug Safety environment.


Key Responsibilities

Case Processing & Safety Data Management

  • Perform end-to-end processing of Individual Case Safety Reports (ICSRs).

  • Review and validate safety information received from:

    • Healthcare Professionals (HCPs)

    • Consumers

    • Clinical Studies

    • Scientific Literature

    • Regulatory Authorities

    • Business Partners

  • Ensure accurate case intake, data extraction, and case creation within safety databases.

  • Perform case triage and prioritization according to client and regulatory requirements.

Adverse Event Reporting

  • Identify and process:

    • Adverse Events (AEs)

    • Serious Adverse Events (SAEs)

    • Adverse Drug Reactions (ADRs)

    • Product Quality Complaints (PQCs)

    • Special Situations

  • Assess case completeness and follow-up requirements.

  • Initiate and track follow-up requests to obtain missing safety information.

MedDRA Coding & Data Quality

  • Perform accurate MedDRA coding for:

    • Adverse Events

    • Medical History

    • Indications

    • Laboratory Data

    • Product Information

  • Ensure consistency and accuracy of coded data.

  • Conduct quality checks and resolve data discrepancies.

Regulatory Compliance & Submissions

  • Support preparation and submission of safety reports in accordance with:

    • Global Pharmacovigilance Regulations

    • ICH Guidelines

    • Good Pharmacovigilance Practices (GVP)

    • Client Standard Operating Procedures (SOPs)

  • Ensure adherence to reporting timelines and regulatory commitments.

  • Maintain inspection-ready documentation and audit compliance.

Safety Database Management

  • Enter and maintain safety data within validated pharmacovigilance databases.

  • Perform case reconciliation and data verification activities.

  • Support database cleanup and quality improvement initiatives.

  • Ensure complete and accurate documentation of all case activities.

Collaboration & Communication

  • Work closely with:

    • Drug Safety Teams

    • Medical Reviewers

    • Pharmacovigilance Physicians

    • Quality Assurance Teams

    • Regulatory Affairs Teams

  • Escalate complex cases and safety concerns to senior team members.

  • Communicate case-related updates and issues to supervisors as required.

Quality & Process Excellence

  • Follow established workflows, SOPs, and work instructions.

  • Contribute to continuous improvement initiatives within pharmacovigilance operations.

  • Support internal audits, inspections, and compliance activities.

  • Maintain high levels of productivity, accuracy, and quality metrics.


Required Qualifications

Education

  • Bachelor of Pharmacy (B.Pharm)

OR

  • Master of Pharmacy (M.Pharm)

Experience

  • 3–5 years of experience in:

    • Pharmacovigilance Operations

    • Drug Safety

    • ICSR Processing

    • Adverse Event Reporting

    • Safety Database Management