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Pharmacovigilance Services Analyst

Accenture
Accenture
2-5 years
preferred by company
Chennai, India
2 May 14, 2026
Job Description
Job Type: Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Pharmacovigilance Services Analyst
Location: Chennai, Tamil Nadu, India
Employment Type: Full-Time
Job Category: Pharmacovigilance / Drug Safety / Clinical Safety Operations
Experience Required: 3–5 Years

 


Job Overview

An excellent opportunity is available for an experienced Pharmacovigilance Services Analyst to join a high-performing global drug safety operations team. This role is ideal for professionals with expertise in pharmacovigilance operations, ICSR review, adverse event processing, drug safety surveillance, and regulatory compliance.

The selected candidate will be responsible for reviewing, evaluating, and quality-checking individual case safety reports (ICSRs) within global safety databases while ensuring compliance with regulatory requirements, client SOPs, and pharmacovigilance quality standards.

This role is suited for candidates with strong knowledge of medical terminology, pharmacovigilance workflows, safety databases, MedDRA, WHO-Drug coding, and global safety reporting processes.


Key Responsibilities

ICSR Review & Drug Safety Case Management

  • Perform quality review and evaluation of Individual Case Safety Reports (ICSRs)
  • Ensure accurate safety case processing in compliance with regulatory timelines and client SOPs
  • Review adverse event data for completeness, accuracy, and consistency
  • Assess seriousness, causality, and expectedness of reported events
  • Escalate complex cases to medical reviewers or validators when required

Safety Data Processing & Quality Control

  • Review medical history, laboratory results, therapy dates, and source documentation for case accuracy
  • Validate safety database entries and update records where corrections are needed
  • Identify case processing errors and document findings in quality control systems
  • Manage case corrections, clarifications, follow-ups, and case closure activities

Regulatory Compliance & Reporting

  • Ensure compliance with global pharmacovigilance regulations and internal quality procedures
  • Support responses related to regulatory authority product safety requests
  • Maintain documentation standards aligned with pharmacovigilance audit and inspection readiness

Case Follow-up & Stakeholder Coordination

  • Identify missing case information and initiate follow-up actions
  • Coordinate with internal teams, client stakeholders, and marketing companies for clarifications
  • Archive all source documents, communications, and reports in the global safety database

Operational Excellence

  • Meet turnaround time (TAT), SLA, KPI, and regulatory submission timelines
  • Participate in transition activities and process improvement initiatives
  • Complete required pharmacovigilance and compliance training programs
  • Adapt to role transitions based on business needs

Required Qualifications

Educational Qualifications
Candidates should hold one of the following:

  • Bachelor of Pharmacy (B.Pharm)
  • Master of Pharmacy (M.Pharm)
  • BHMS
  • Bachelor’s degree in Life Sciences or equivalent healthcare-related qualification