Vanaja Pilli

About Vanaja Pilli

With a MS Pharm degree and over 10 years of experience in pharmacovigilance and software product testing, worked as a Subject matter expert at ArisGlobal, a leading provider of software solutions for the life science industry. My mission is to ensure the quality, compliance, and performance of the software solutions that support the safety and efficacy of drugs and medical devices.My core competencies include pharmacovigilance and drug safety regulations, case processing across various therapeutic areas, risk management and signal detection, computer system validation, and team management. I am passionate about learning new technologies and applying them to solve complex problems in the life science and IT domains. Experience in Pharmacovigilance safety with strong knowledge of Pharmacovigilance and Drug Safety regulations (ICH, GxP, GVP modules with new Pharmacovigilance legislation, 21CFR Part 11, FDA, EU Annex 11, Health Canada and GAMP 5 Standards). Worked on ARISg, AgXchange, LSMV, LSSMV, LSIT, Remetrex Safety System (RSS), MedDRA and WHODD. Initiative-taking with commendable presentation, written, interpersonal, analytical and critical thinking skills. Exceptional ability to develop, motivate and mentor members of the staff to meet all deliverables and align with a career path. Ability to be flexible, adapt to change, work independently as well as part of a team in a matrix environment required to interact with clients, management and peers effectively. Expertise in writing or quality reviewer of pharmacovigilance documents including PSUR, DSUR and PBRER, PADER. Enthusiastic to create innovative solutions that empower business to deliver value. My strength lies in working under pressure, problem solving, collaborating with cross functional teams, delivering stakeholders expectations within deadlines while maintaining an unclouded vision. Managing, prioritizing and Resource planning within the case management team. Experience in Computer System Validation for Life Sphere products. Involved in planning and executing different testing as required for the validation of the system including Installation Qualification (IQ), Operational Qualification (OQ), and User Acceptance Testing (UAT) which included identification of scenarios, test script authoring, test script execution, defect reporting, planning tasks and driving test execution to closure for the projects. Involved in the documentation and review of project deliverables following GDP principles and in the management on Non-conformities, Root Cause Analysis and CAPAs.

Experience

1. Strategy & Transformation Consultant

   Capgemini

   Jan 2025 — Present · Hyderabad, IN

Education

• Bapatla College of Pharmacy

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

• National Institute of Pharmaceutical Education and Research

  M.S.Pharm, Pharmacology and Toxicology