Senior Expert-Pharmacovigilance IT Systems Specialist

Job Title: Pharmacovigilance IT Systems Specialist Your Role: As a Pharmacovigilance IT Systems Specialist, you will be tasked with supporting, maintaining, and enhancing the pharmacovigilance system to ensure adherence to regulatory standards. You will take the lead in implementing and continuously improving safety databases, ensuring data integrity and compliance with regulations. Collaboration with cross-functional teams will be essential as you integrate new technologies and processes. Additionally, you will act as a primary point of contact for system users and technical teams, owning the entire lifecycle of system changes. This role is pivotal in shaping and optimizing safety database configurations, ensuring they are strategically aligned with evolving business needs and future growth. The role will be based in Bangalore, India, and reporting to Team Lead, Pharmacovigilance Services. Who You Are: • A university degree in information technology or equivalent. • Over 10 years of experience with drug safety database systems in the pharmaceutical industry, healthcare organizations, or software application vendors. • In-depth knowledge of LSMV and pharmacovigilance systems, along with drug safety regulatory requirements (ICH, GVP, FDA CFR Part 11, GxP). • Strong understanding of software validation processes and methodologies (GAMP). • Proven experience in IT project management, service delivery, or vendor management is advantageous. • Exceptional organizational skills with the ability to prioritize tasks and quickly adapt to shifting priorities. • A collaborative team player who considers the broader goals beyond individual targets. • Excellent written and verbal communication skills in English. • Strong interpersonal skills in an international setting.