Senior Pharmacovigilance Associate (Post-Marketing Case Processing)
Company: ICON plc
Location: Chennai
Work Model: Hybrid
Employment Type: Full-time
Experience Required: 4+ Years
Salary (India Estimate): ₹10 LPA – ₹18 LPA
Job Overview
ICON plc is seeking a Senior Pharmacovigilance Associate specializing in Post-Marketing Case Processing.
In this role, you will play a key part in monitoring drug safety and managing adverse event reports for marketed pharmaceutical products. You will collaborate with global teams to ensure pharmacovigilance activities meet international regulatory standards while maintaining high-quality patient safety monitoring.
Key Responsibilities
Perform Individual Case Safety Report (ICSR) processing for marketed pharmaceutical products.
Evaluate adverse event reports including seriousness, expectedness, and causality assessment.
Ensure compliance with global safety reporting requirements and regulatory timelines.
Support literature case processing and reconciliation processes.
Contribute to aggregate safety reports such as PSURs and DSURs.
Analyze safety data to identify trends or potential safety signals.
Maintain accuracy and integrity of pharmacovigilance databases.
Participate in audits and regulatory inspections to ensure compliance.
Train and mentor junior pharmacovigilance staff on case processing procedures and regulatory requirements.
Required Qualifications
Bachelor’s or Master’s degree in one of the following fields:
Pharmacy (B.Pharm / M.Pharm / Pharm.D)
Nursing (B.Sc / M.Sc Nursing)
Dentistry (BDS)
Ayurveda (BAMS)
Homeopathy (BHMS)
Required Experience & Skills
4+ years of pharmacovigilance experience, particularly in post-marketing case processing.
Experience in ICSR processing and adverse event reporting.
Knowledge of global pharmacovigilance regulations and reporting guidelines.
Familiarity with SDEA, KPI/SLA management, and reconciliation processes.
Strong analytical and critical thinking skills for safety data interpretation.
Experience with pharmacovigilance databases and data management systems.
Excellent communication and teamwork skills.
Ability to manage multiple tasks in a fast-paced clinical research environment.
Benefits
Employees at ICON plc receive competitive benefits such as:
Competitive salary and performance incentives
Paid annual leave and holidays
Comprehensive health insurance for employees and families
Retirement planning programs
Global Employee Assistance Programme (LifeWorks) for wellbeing support
Life insurance coverage
Flexible benefits including gym memberships, childcare support, and travel subsidiess
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