Shalini Kolluri
Cspv (Clinical Safety & Pharmacovigilance) Project Manager @Daiichi Sankyo US
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WORK HISTORY
Cspv (Clinical Safety & Pharmacovigilance) Project Manager @Daiichi Sankyo US
US
Led cross-functional pharmacovigilance (PV) initiatives by collaborating with experts in oncology, pediatrics, dermatology, allergy, and ocular safety through Special Knowledge Groups (SKGs). Synthesized expert input to support Product Safety Leads on complex safety issues.Managed PV consultant/vendor contracts using trackers and created SOP-aligned job aids. Used Smartsheet and SharePoint to streamline deliverables, timelines, and documentation.Co-led a global Business Continuity Plan (BCP) simulation with Data Management and Systems Ops to ensure uninterrupted safety case processing during crises. Coordinated protocols with safety ops, regulatory, and case processing teams.Maintain clear communication and coordination between internal teams and vendors to ensure smooth safety data management and compliance with SOPsDeveloped a SharePoint Center of Excellence for PV teams, focusing on governance, training, and collaboration across global functions including aggregate reporting and risk management.Supported global epidemiology projects by transitioning workflows into Smartsheet, aligning with EU teams on scope, timelines, and deliverables, and contributing to population-level safety analyses.Delivered internal presentations on PV project status, safety trends, compliance metrics, and stakeholder engagement.
EDUCATION
KVG Medical College Sullia
Bachelor of Medicine, Bachelor of Surgery - MBBS
University of San Francisco
Master's degree
ABOUT SHALINI KOLLURI
With 12 years of experience in healthcare, including over 6 years in drug safety and…
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