Senior Pharmacovigilance Associate

Role Overview This is a full-time Senior Pharmacovigilance Associate opportunity based in Chennai, Tamil Nadu, with a leading global clinical research organization. The role is ideal for professionals with 4 or more years of hands-on experience in pharmacovigilance case processing, particularly in Post-Marketing Surveillance and Clinical Trial safety. You will play a key role in safeguarding patient safety by managing end-to-end drug safety activities and ensuring timely regulatory compliance. Key Responsibilities - Process and review Individual Case Safety Reports (ICSRs) for marketed products and clinical trial cases with a focus on quality and accuracy - Evaluate adverse event reports for seriousness, expectedness, causality, and submit within global regulatory timelines - Prepare and submit Periodic Safety Update Reports (PSURs), DSURs, and other regulatory safety documents in line with international standards - Perform literature ICSR processing and ensure compliance with ongoing monitoring requirements - Conduct signal detection activities and analyze safety data trends to identify potential safety concerns requiring further investigation - Maintain pharmacovigilance databases and uphold documentation quality in accordance with data management protocols - Collaborate with medical, clinical, and cross-functional teams to assess the clinical significance of reported adverse events - Support risk management initiatives and contribute to the development and review of Standard Operating Procedures (SOPs) - Train and mentor junior pharmacovigilance associates on case processing, regulatory requirements, and industry best practices - Participate in regulatory audits and inspections, ensuring readiness and full compliance at all times - Stay current with evolving global pharmacovigilance regulations and incorporate updates into existing processes Required Qualifications - Minimum 4 years of experience in pharmacovigilance or drug safety with hands-on case processing and quality control in Post-Marketing or Clinical Trial cases - Solid knowledge of ICSR processing, seriousness, expectedness, causality assessment, and global reporting timelines - Familiarity with reconciliation processes, aggregate reporting, SDEA frameworks, and KPI or SLA monitoring - Proven ability to manage pharmacovigilance workflows including adverse event reporting and signal detection - Strong analytical and critical thinking skills with the ability to interpret complex safety data - Excellent verbal and written communication skills with experience working across cross-functional teams - Proficiency in pharmacovigilance database systems and Microsoft Office Suite - Ability to independently manage multiple priorities in a fast-paced, deadline-driven environment - High level of discretion in handling confidential patient safety information Why Join Us This organization is committed to building an inclusive, high-performance culture that nurtures talent and rewards excellence in clinical research. Employees benefit from a comprehensive global benefits package, flexible work-life balance initiatives, and access to a worldwide employee assistance programme supporting personal and professional well-being.

- 4 or more years of pharmacovigilance or drug safety experience - Hands-on ICSR case processing and QC in Post-Marketing or Clinical Trial settings - Knowledge of seriousness, expectedness, causality, and global reporting timelines - Experience with PSUR, DSUR, and aggregate safety reporting - Familiarity with SDEA, reconciliation processes, and KPI or SLA basics - Proficiency in pharmacovigilance databases and Microsoft Office Suite - Strong analytical, communication, and cross-functional collaboration skills - Experience mentoring junior staff and reviewing SOPs - Ability to participate in regulatory audits and inspections

- Competitive salary with performance-based rewards - Annual leave entitlements as per company policy - Health insurance coverage for employee and family - Retirement and pension planning support - Life assurance coverage - Access to global Employee Assistance Programme available 24 hours a day - Flexible country-specific optional benefits including gym memberships, childcare vouchers, and travel passes - Inclusive workplace culture with equal opportunity employment