Senior Pharmacovigilance Associate

Role Overview ICON plc is a globally recognized leader in healthcare intelligence and clinical research. As a Senior Pharmacovigilance Associate based in Chennai, you will play a central role in safeguarding the safety and efficacy of pharmaceutical products by overseeing end-to-end pharmacovigilance activities across both Post-Marketing Surveillance and Clinical Trial case processing. This is a mid-senior level, full-time opportunity suited for professionals with strong hands-on experience in ICSR processing and drug safety operations. Key Responsibilities - Process and quality-check Individual Case Safety Reports (ICSRs) for marketed products and clinical trials in compliance with global regulatory standards - Evaluate adverse event reports for seriousness, expectedness, causality, and ensure timely and accurate submission to regulatory authorities - Prepare and submit Periodic Safety Update Reports (PSURs), DSURs, and other regulatory safety documents in line with international compliance requirements - Analyse pharmacovigilance data to identify trends, signals, and potential safety issues requiring further investigation or escalation - Collaborate closely with medical, clinical, and cross-functional teams to determine the clinical significance of reported adverse events and support risk management activities - Maintain the integrity and compliance of pharmacovigilance databases and uphold documentation quality per data management protocols - Support reconciliation processes, aggregate reporting, SDEA activities, and adherence to KPI and SLA requirements - Train, mentor, and guide junior pharmacovigilance staff on case processing procedures, regulatory standards, and industry best practices - Review and update Standard Operating Procedures (SOPs) as required - Participate actively in regulatory audits and inspections, ensuring the team maintains readiness and full compliance at all times - Stay current with evolving global pharmacovigilance regulations and incorporate relevant updates into existing processes Required Qualifications - Minimum 4 years of experience in pharmacovigilance or drug safety with a focus on ICSR case processing and quality control - Hands-on experience specifically in Post-Marketing Surveillance and/or Clinical Trial case handling - Solid understanding of global safety reporting regulations, seriousness and causality assessment, and expectedness criteria - Familiarity with reconciliation processes, aggregate reporting formats including PSUR and DSUR, and SDEA guidelines - Proven ability to detect signals and manage the full pharmacovigilance process from adverse event intake to regulatory submission - Strong analytical, critical thinking, and problem-solving skills with the ability to interpret complex safety data - Proficiency in pharmacovigilance database systems and Microsoft Office Suite - Excellent written and verbal communication skills with the ability to collaborate across cross-functional and global teams - Ability to independently manage multiple priorities and deliverables in a fast-paced, deadline-driven environment - High level of discretion in handling confidential patient and safety data Why Join Us ICON plc offers a competitive compensation package alongside a comprehensive suite of benefits focused on employee well-being, work-life balance, health coverage, retirement planning, and global support through the LifeWorks Employee Assistance Programme. You will be part of an inclusive, innovation-driven culture that values diversity, recognizes high performance, and actively invests in the growth of its people.

- Minimum 4 years of pharmacovigilance or drug safety experience - Hands-on ICSR case processing and QC for Post-Marketing and/or Clinical Trial cases - Knowledge of seriousness, expectedness, causality, and global safety reporting - Experience with PSUR, DSUR, and aggregate reporting - Familiarity with reconciliation processes and SDEA guidelines - Awareness of KPI and SLA requirements in pharmacovigilance operations - Proficiency in pharmacovigilance databases and data management systems - Strong analytical and critical thinking skills - Excellent communication and cross-functional collaboration skills - Ability to mentor junior staff and review SOPs - Experience supporting regulatory audits and inspections - Proficiency in Microsoft Office Suite

- Competitive salary package - Annual leave entitlements - Comprehensive health insurance options for employees and families - Retirement and pension planning offerings - Life assurance coverage - Global Employee Assistance Programme via LifeWorks with 24/7 access - Flexible country-specific optional benefits including gym memberships and health assessments - Childcare vouchers and subsidized travel passes (where applicable) - Inclusive and diverse work culture with strong focus on employee well-being