PHARMAFull-time
Senior Pharmacovigilance Associate
CHENNAI (IN)HYBRIDPOSTED: 8/18/2026
PHARMAFull-time
HIRING ORGANIZATIONICONContract Research Organization (CRO) / Clinical Research / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Manage and oversee end-to-end pharmacovigilance and drug safety operations to ensure the safety and efficacy of pharmaceutical products.
Lead the collection, evaluation, narrative writing, quality control (QC), and end-to-end processing of adverse event reports and ICSRs for Post-Marketing Surveillance (PMS) and Clinical Trials.
Evaluate case seriousness, expectedness, listedness, and causality assessments to ensure compliant, on-time submissions to global health authorities.
Process literature ICSRs and adhere strictly to global regulatory monitoring timelines and requirements.
Perform safety data reconciliation processes and contribute to the preparation and review of aggregate safety reports, including Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
Partner with medical and clinical review teams to determine the clinical significance of adverse events and support risk management initiatives.
Quality, Compliance & Audit Readiness
Maintain the integrity, compliance, and quality documentation within global safety databases according to data management protocols.
Support regulatory audits and sponsor inspections by maintaining continuous audit readiness and regulatory adherence.
Monitor Safety Data Exchange Agreements (SDEAs) and maintain compliance with critical KPIs and SLA metrics.
Leadership & Mentorship
Mentor, train, and guide junior safety associates on case processing standards, medical terminology, and standard operating procedures (SOPs).
Review and update SOPs, work instructions, and safety guidelines to align with evolving global regulatory frameworks.
Benefits & Total Rewards
Competitive base salary with performance-related incentives and annual bonuses.
Comprehensive health and wellbeing programs covering medical, dental, and vision care.
Retirement, pension plans, life assurance, and disability coverage.
Structured career pathways and continuous professional development programs.
REQUIRED VERIFIED SKILLS
Pharmacovigilance
ICSR Processing
Post Marketing Surveillance (PMS)
Clinical Trial Case Processing
Quality Control (QC)
Causality Assessment
Seriousness Assessment
Aggregate Reporting (PSUR/DSUR)
Literature Screening
Safety Data Reconciliation
SDEA
COMPENSATION & REWARDS
₹7.0L - 12.0L per annum
ORGANIZATION CONTEXT & CULTURE
ICON plc is a global provider of outsourced drug development and commercialization services to pharmaceutical, biotechnology, medical device, and government organizations. The company specializes in a broad range of clinical research services, from Phase I-IV studies to consulting and data solutions. ICON helps its clients accelerate the development of drugs and devices through comprehensive scientific and operational expertise.
TEAM SIZE: 41,100+ employees
INDUSTRY: Contract Research Organization (CRO) / Clinical Research / Healthcare Services
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.