Pharmacovigilance Associate

ICON plc

. Collect, assess, and process adverse event reports to ensure accuracy and timely compliance with regulatory requirements .

Posted 10/8/2026full-timeChennai • IndiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance, including case processing, regulatory compliance, and safety reporting. Proficient in data analysis, communication, and collaboration within cross-functional teams to ensure high-quality safety standards.

Highest-signal resume keywords

Pharmacovigilance RegulationsCase ProcessingPost Marketing SurveillanceMedDRA/WHO-DD CodingAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Case TriageData EntryNarrative WritingQuality Control ChecksAggregate ReportingSDEA KnowledgeKPI/SLA BasicsICSR Processing

Soft Skills

Attention to DetailCommunication SkillsInterpersonal SkillsCollaboration

Tools & Technologies

Safety Database

Industry Keywords

Adverse Event ReportsGlobal Safety GuidelinesComplianceSeriousnessExpectednessCausalityMonitoring Requirements

About the role

Key responsibilities & impact

Collect, assess, and process adverse event reports to ensure accuracy and timely compliance with regulatory requirements
Partner with cross-functional teams to address safety-related questions and support ongoing investigations
Maintain current knowledge of pharmacovigilance regulations, global safety guidelines, and industry standards
Manage safety inbox and acknowledge case receipt
Perform case triage and book-in to safety database
Enter case details accurately and write narratives
Code events, drugs, and medical history using MedDRA/WHO-DD
Apply correct product labeling and perform QC checks
Finalize case processing and generate queries for follow-up
Apply knowledge of seriousness, expectedness, causality, and global reporting
Perform reconciliation processes and aggregate reporting (PSUR/DSUR)
Mentor new joiners and review SOPs
Apply working knowledge of SDEA and KPI/SLA basics
Process literature ICSRs and maintain compliance with monitoring requirements

Requirements

What you’ll need

Minimum 2 years of experience in safety background, with direct involvement in case processing
Solid experience in Post Marketing Surveillance/Clinical Trial case processing
Bachelors degree in life sciences
Strong analytical skills with attention to detail in data collection and reporting
Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders
A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities
Legal right to work in the country where the role is based

Benefits

Comp & perks

Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways