Aishwarya Singh

Actively pursuing a dynamic position in the healthcare industry, specializing in clinical trials, coding, safety, and pharmacovigilance, to apply expertise and experience in driving the progress of clinical research and targeting positions in Pune, Mumbai, and Gujarat, also open to work in remote positions.

Job Summary

• 7.5 Years of experience in managing clinical research billing operations and Pharmacovigilance ensuring strict adherence to industry regulations
• Expertise in executing pharmacovigilance activities, encompassing accurate adverse events reporting and vigilant safety monitoring.
• Exhibit exceptional skills in orchestrating clinical research studies, managing study timelines, and ensuring the utmost accuracy of data.
• Possess an extensive understanding of clinical practice (GCP), FDA regulations, and ICH guidelines, displaying a robust knowledge base in the field.
• Wealth of experience in conducting trial feasibility assessments, reviewing clinical trial documents, and providing comprehensive support solutions for coverage analysis
• Display a proven track record of expertise in the specialized fields of Oncology and Diabetology, delivering exceptional results in therapeutic areas.
• Displayed comprehensive knowledge and expertise in adhering to Medicare and private payer billing requirements, ensuring strict compliance.
• Skilled in CTMS and eTMF systems like Veeva Vault and TMF Reference Model implementation.
• Highly skilled in conducting trial feasibility assessments and clinical trial document reviews, ensuring efficient study planning and execution.
• Proficient in developing and maintaining strong relationships with sponsors, vendors and study sites resulting in successful negotiation of contracts and seamless collaboration throughout the trial lifecycle.
• Track record of successfully multitasking, effectively managing priorities, and adeptly adapting to the ever-changing demands of projects
• Provided support, training, and guidance to new hires on project deliverables, fostering a positive and productive learning environment.