Shraddha Ghude
Senior Director, PV Sciences, Taiho Oncology, Inc.
- Role
- Senior Director, Pharmacovigilance Sciences at Taiho Oncology, Inc.
- Location
- Dover, NJ, US
- LinkedIn followers
- 500 followers
About Shraddha Ghude
Accomplished Pharmacovigilance leader with 20+ years of experience building and mentoring high-performing, cross-regional teams. • Expert in leading system integrations and collaborating with regulators and CROs to deliver audit-ready, on-time results. • Recognized for visionary leadership—coaching scientists and physicians, streamlining workflows, and empowering teams to excel in managing both developmental and marketed products. • Proven track record in inspection readiness, risk management, and compliance oversight, with a focus on building robust safety systems. • Skilled communicator and relationship builder, adept at managing people, processes, and partnerships with internal and external stakeholders.
Experience
Senior Director, Pharmacovigilance Sciences
Jan 2021 — Present · Princeton, NJ, US
Strategic Leadership in all aspects of pharmacovigilance while ensuring high standards of quality, compliance and operational excellence across the organization- Maintain critical oversight of people management, process management, and the Quality Management System- Maintain compliance with global pharmacovigilance oversight, with responsibilities including medical surveillance of developmental/marketed products, aggregate reports and signal management.
Skills
- U.s. Food and Drug Administration (Fda)
- Microsoft Excel
- Problem Solving
- Sop Development
- Management
- Team Building
- Leadership
- Clinical Development
- Microsoft Word
- Oncology
- Regulatory Affairs
- Biotechnology
- Clinical Trials
- Pharmaceutical Industry
- Fda
- Pharmacovigilance
- Validation
- Gcp
- Clinical Research
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