Senior Pharmacovigilance Associate – Post Marketing Surveillance (LSMV Database)
Company: ICON plc
Location: Chennai, India
Work Model: Office with Flex (Hybrid)
Employment Type: Full-Time
Experience Level: Senior (4+ Years)
Job ID: JR139662
Job Overview
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking an experienced Senior Pharmacovigilance Associate to join its Safety and Vigilance team in India. This role is focused on post-marketing pharmacovigilance activities, including ICSR processing, safety database management (LSMV), regulatory compliance, and team mentorship. The position plays a critical role in ensuring patient safety and regulatory adherence across global markets.
Key Responsibilities
Lead end-to-end processing of Individual Case Safety Reports (ICSRs) for marketed products in compliance with global regulatory timelines
Perform medical and regulatory assessment of cases, including seriousness, expectedness, causality, and global reporting requirements
Ensure accurate data entry, review, and quality control within the LSMV safety database
Manage reconciliation activities and contribute to aggregate safety reporting, including PSURs and DSURs
Process literature-derived ICSRs and maintain compliance with monitoring requirements
Maintain pharmacovigilance documentation in alignment with SOPs, KPIs, SLAs, and regulatory standards
Identify safety trends and support signal detection and risk management activities
Collaborate with medical, clinical, and cross-functional teams to assess clinical relevance of adverse events
Mentor and train junior pharmacovigilance associates and contribute to SOP reviews and process improvements
Support internal and external audits and regulatory inspections, ensuring inspection readiness
Stay current with evolving global pharmacovigilance regulations and industry best practices
Education & Experience Requirements
Minimum 4+ years of experience in pharmacovigilance case processing, specifically in Post-Marketing Surveillance
Proven hands-on experience with ICSR processing for marketed products
Educational qualification in one of the following:
B.Pharm / M.Pharm
Pharm.D
BDS
B.Sc Nursing / M.Sc Nursing
BAMS / BHMS
Required Skills & Competencies
Strong knowledge of global pharmacovigilance regulations and reporting standards
Working knowledge of aggregate reporting (PSUR, DSUR) and reconciliation processes
Experience with safety data exchange agreements (SDEA) and KPI/SLA management
Proficiency in pharmacovigilance databases, particularly LSMV
Strong analytical and critical thinking skills with high attention to detail
Excellent written and verbal communication skills
Ability to manage multiple priorities independently in a fast-paced environment
High standards of data integrity, confidentiality, and compliance
Why Join ICON
ICON’s success is driven by its people. The organization fosters a high-performance, inclusive culture that values innovation, collaboration, and professional growth. Employees benefit from competitive compensation, flexible work arrangements, and comprehensive well-being programs designed to support work-life balance.
Diversity, Equity & Inclusion
ICON is committed to creating an inclusive and accessible workplace. All qualified applicants receive equal consideration for employment without discrimination based on race, religion, gender, disability, or any other protected characteristic. Reasonable accommodations are available throughout the recruitment process.
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