15 Oct
|
Bristol-Myers Squibb
|
Hyderabad
15 Oct
Bristol-Myers Squibb
Hyderabad
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver cutting-edge medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
The Patient Safety group is responsible for ensuring the safety of our medicines: The Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements. The QPPV support team is headed by the QPPV (EEA & UK QPPV)
and is an expert interface for regulatory and scientific requirements and build the interface between Local/Regional safety regulatory environment and Global product Teams, both in development and post-marketing. The QPPV team contributes & appropriately review EU RMPs, PSURs/PBRERs, PASS & other PV documents, engages/coordinates PRAC activities and participates in Scientific Advice and similar forums. The Senior Manager, Global PV System Excellence & QPPV support Patient Safety role will support the organization by:
• Manage safety actions screening process of Health Authority website for Countries where BMS is acting as Marketing Authorization Holder
• Support Safety Aggregate reports Health Authorities submission activities (i.e. submission package documentation, late submission Verity tracking etc) as applicable
• Liaise on matters related to (CAP) PSUR preparation and communication
• Coordination rol
📌 Senior Manager, Global PV System Excellence (Hyderabad)
🏢 Bristol-Myers Squibb
📍 Hyderabad