Priyankini Srinivasan

A well-versed clinical research professional with over a decade of experience in global pharmacovigilance, publication writing, and aggregate reporting for clinical development programs. Proficient in adverse event reporting and aggregate reporting, providing comprehensive analysis of data. Skilled in working with clinical and safety databases and adept in performing regulatory submissions of expedited safety reports. Demonstrated expertise in enhancing drug safety processes and driving continuous improvement initiatives.

Associate Manager at Labcorp Clinical Development Pvt. Ltd. India Jan 2019 to Oct 2022 Leveraged expertise in safety data analysis to author and review aggregate reports for multiple projects, demonstrating exceptional project management skills and ability to handle deadlines and regulatory complexities. 
• Spearheaded the comprehensive execution of Development Safety Update Report (DSUR)/Annual Safety Report (ASR) process from kick-off meeting to finalization, achieving 100% on-time regulatory submission. 
• Orchestrated cross-functional collaboration with clinical, data management, drug safety, regulatory, biostatistics, and vendors, to streamline safety data collection and report compilation processes. 
• Generated and reviewed line listings and summary tabulations, significantly improving report accuracy. 
• Authored entire sections of DSUR by evaluating the overall safety profile of investigational drug, analyzing extensive data from trials, literatures, other sources and identifying any potential safety risks or signals. 
• Developed and optimized DSUR/ASR processes including workflow trackers, resource allocation, process flowchart, trainings, job-aids, quality control checklists, resulting in 30% increase in operational efficiency.

Senior Drug Safety Associate at Labcorp clinical Development Pvt. Ltd. India Aug 2016 to Jan 2019 
Led and managed a wide range of drug safety and pharmacovigilance operational activities for partial and full scope clinical trials projects and served as project responsible person. 
• Determined Regulatory Reporting Requirements (RRR) to perform accurate and timely electronic and manual submission of Suspected Unexpected Serious Adverse Reactions (SUSARs) to Regulatory Authorities, Investigators, Review Boards, and Business Partners. 
• Led project specific training programs for submission team, resulting in 30% increase in team productivity. 
• Proactively highlighted error trends, participated in continuous improvement process, and implemented trainings to improve quality on all aspects of case-handling, reporting, and drafting narratives.
•Monitored workflow for assigned studies to ensure deadlines are met and compliant with safety reporting. 
• Prepared team for sponsor audit and ensured the inspection findings relating to products of responsibility were addressed implementing effective Corrective and Preventive Action Plans (CAPA). 
• Worked with data management on reconciliation of SAEs and tracked compliance and submission trackers.

Senior Drug Safety Associate at ICON Clinical Research Pvt. Ltd. India Oct 2013 to Aug 2016 
Served as a quality reviewer to validate the databased adverse events to ensure accurate, complete, and consistent data entry is performed in Argus database. 
• Executed user acceptance testing (UAT) activities ranging from reviewing test scripts to conducting dry runs and formal execution testing for new projects or migration projects.
• Contributed to preparing documents such as data transfer plan and data transfer requirement specification (mapping document) and successfully carried out data migration activities. 
• Collaborated with Argus Systems team in safety database set up and configuration of enterprises. 
• Validated the databased adverse events to ensure if data have been transcribed accurately, completely, and consistently to relevant fields in Argus database according to global safety and regulatory compliance. 
• Reviewed the adverse event for seriousness, causality, expectedness, and ensured clear concise narratives are drafted along with raising appropriate follow-up queries for complete analysis. 
• Generated safety reports (MedWatch/CIOMS) for reporting purposes and line listings for aggregate reports and signal detection.

• Master of Business Administration, Anna University, India 
• Bachelor of Dental Surgery, Dr. M.G.R. Medical University, India