PHARMAFull-time
Pharmacovigilance Associate
By Admin · Pharmacovigilance & Drug Safety
CHENNAI (IN)HYBRIDPOSTED: 9/10/2026
PHARMAFull-time
HIRING ORGANIZATIONICONContract Research Organization (CRO) / Clinical Research / Healthcare Services
ROLE OVERVIEW
Process and assess clinical trial and post-marketing safety cases while ensuring accurate, timely, and compliant pharmacovigilance activities. Support case intake, triage, coding, narratives, quality control, follow-up, and regulatory compliance.
ROLE DEFINITION & RESPONSIBILITIES
- •Collect, assess, and process adverse event reports
- •Manage the safety inbox and acknowledge case receipt
- •Perform case triage and book cases into the safety database
- •Enter case information accurately and write case narratives
- •Code events, drugs, and medical history using MedDRA and WHO-DD
- •Apply product labeling and perform quality control checks
- •Finalize case processing, generate follow-up queries, and support reconciliation and aggregate reporting
- •Process literature ICSRs and maintain monitoring compliance
Reporting Hierarchy: Reports to a Pharmacovigilance/Safety Operations manager or team lead; collaborates with cross-functional safety and clinical research teams
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Minimum 2 years of pharmacovigilance or safety experience
- Hands-on post-marketing surveillance and clinical trial case processing experience
- Bachelor's degree in life sciences
- Strong analytical skills and attention to detail
- Excellent communication and interpersonal skills
- Commitment to quality and regulatory compliance
PREFERRED QUALIFICATIONS
- •Knowledge of aggregate reporting such as PSUR and DSUR
- •Experience with SDEA and KPI/SLA concepts
- •Ability to mentor new joiners and review SOPs
- •Experience with literature ICSRs
REQUIRED VERIFIED SKILLS
Pharmacovigilance
Adverse Event Processing
Clinical Trial Case Processing
Post-Marketing Surveillance
Case Triage
Safety Database
MedDRA
WHO-DD
Case Narratives
Product Labeling
Quality Control
ICSR
Literature Monitoring
PSUR
DSUR
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Competitive base salary and performance incentives; health and wellbeing programmes; medical, dental and vision coverage where applicable; retirement and pension plans; life assurance and disability coverage; employee assistance programmes; learning and development opportunities
The posting does not disclose a salary range. Compensation is described as competitive with performance-related incentives; actual pay depends on experience, location, and ICON's internal compensation structure.
ORGANIZATION CONTEXT & CULTURE
ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines and treatments to patients faster through clinical development and related services.
TEAM SIZE: 40,000+ employees
INDUSTRY: Contract Research Organization (CRO) / Clinical Research / Healthcare Services
Culture: ICON emphasizes integrity, collaboration, agility, inclusion, and a patient-focused mission while supporting employee development and accessibility.
EXPECTED CAREER ROADMAP
Opportunity to progress from Pharmacovigilance Associate into Senior PV Associate, PV Specialist, Case Processing Lead, Safety Operations Lead, or broader pharmacovigilance and drug safety management roles through case expertise, regulatory knowledge, mentoring, and leadership.
APPLICATION ADVISORY
Highlight at least 2 years of direct clinical trial and post-marketing case processing; emphasize MedDRA/WHO-DD coding, case triage, narrative writing, QC, seriousness/expectedness/causality assessment, and ICSR experience; mention PSUR/DSUR, literature cases, SDEA, and KPI/SLA knowledge where applicable.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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