Pharmacovigilance Associate – Clinical Trial & Post-Marketing Safety (LSMV Database)
Company: ICON plc
Location: Chennai, India
Work Model: Office with Flex (Hybrid)
Employment Type: Full-Time
Experience Required: 2+ Years
Job Requisition ID: JR139660
Job Overview
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a skilled Pharmacovigilance Associate to join its Safety and Vigilance team in India. This role focuses on clinical trial and post-marketing safety case processing, with hands-on responsibility for ICSR management using the LSMV safety database. The position plays a key role in ensuring regulatory compliance, data quality, and patient safety across global programs.
Key Responsibilities
Receive, triage, and process Individual Case Safety Reports (ICSRs) in compliance with global regulatory timelines
Manage safety inboxes and acknowledge receipt of adverse event cases
Perform case book-in, data entry, and narrative writing within the LSMV safety database
Code adverse events, medical history, and medications using MedDRA and WHO-DD
Apply correct product labeling and perform quality control (QC) checks
Assess seriousness, expectedness, causality, and global reporting requirements
Finalize case processing and generate follow-up queries as required
Process literature-derived ICSRs and ensure compliance with monitoring obligations
Support reconciliation activities and contribute to aggregate reporting, including PSURs and DSURs
Collaborate with cross-functional teams to resolve safety-related queries and investigations
Maintain compliance with SOPs, SDEAs, KPIs, SLAs, and global pharmacovigilance regulations
Assist in mentoring new team members and supporting SOP reviews
Education & Experience Requirements
Minimum 2+ years of experience in pharmacovigilance case processing, specifically in Post-Marketing Surveillance
Hands-on experience in clinical trial or marketed product safety case processing
Educational qualification in one of the following disciplines:
B.Pharm / M.Pharm
Pharm.D
BDS
B.Sc Nursing / M.Sc Nursing
BAMS / BHMS
Required Skills & Competencies
Strong understanding of global pharmacovigilance regulations and reporting standards
Practical experience with safety databases, preferably LSMV
Knowledge of reconciliation processes and aggregate safety reporting
High attention to detail with strong analytical and documentation skills
Excellent written and verbal communication abilities
Ability to work collaboratively in cross-functional and global teams
Commitment to data integrity, confidentiality, and regulatory compliance
Ability to manage workload effectively in a deadline-driven environment
Why Join ICON
ICON is committed to building a diverse, inclusive, and high-performance culture. Employees benefit from competitive compensation, flexible working models, and comprehensive benefits designed to support professional growth, well-being, and work-life balance.
Diversity, Equity & Inclusion
ICON is an equal opportunity employer committed to providing an inclusive and accessible workplace. All qualified applicants will receive equal consideration regardless of race, gender, disability, religion, or other protected characteristics. Reasonable accommodations are available throughout the recruitment process.
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