Madhav Kumar Goud

Experience

1. Senior Associate Consultant

   Infosys

   Dec 2024 — Present · Hyderabad, IN

   Primary liaison between clients and the project team, understanding project needs,and translating them into actionable project plans.Oversee the planning, execution, and completion of Pharmacovigilance projects,ensuring they meet study timelines, and budget constraints.Provided GPS (Global Patient Safety) input to Safety Management Plans (SMPs),Global reporting procedures and other key pharmacovigilance documents.Representing the PV function during internal audits and health authority inspectionsas a subject matter expert on safety reporting within clinical programsFacilitate Initial project Kick off meetings.Communicate findings, recommendations, and project updates to stakeholders andexecutives.Collaborated with cross-functional study teams to align clinical operations withsafety reporting objectives and pharmacovigilance standards.Supported activities ensuring accurate collection and reporting of adverse event (AE)data from clinical trials, expanded access programs, and post-trial activities.Participating in regular cross-functional governance meetings to review safety datatrends and operational consistency.Maintaining inspection readiness in accordance with the PV System Master File andGood Pharmacovigilance Practices (GVP) guidelines.Ensured accurate tracking and timely submission of ICSRs (individual case safetyreports) per regulatory timelines.Provided training and support to team members on pharmacovigilance processesand documentation.