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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLE PHONE NUMBER AVAILABLE New JerseySUMMARY Vibrant and goal-oriented professional with 17 years of experience in the Information Technology industry. Over 16 years of US Pharmaceutical domain expertise in delivering technology solutions in Pharmacovigilance, Clinical Safety, Drug Safety, and Safety Reporting for Life Sciences industry. Eloquently familiar with Clinical Development and Pharmacovigilance Lifecycle. Excellent understanding of the business operations within Pharmacovigilance and Clinical Safety. Expert knowledge of Global and FDA Regulations supporting the submission of Adverse Events for Post- marketing and Clinical Trials drugs. Understanding of ICH guidelines on PV and application of guidelines detailed in FDA 21 CFR Part 11, including Computer System Validation Requirements. Highly proficient in Drug Safety Systems and PV Reporting and Analytical solutions. Exceptional in Project Management, Planning and Deploying corporate-level business applications. Brilliant communication, interpersonal skills, and strategic thinking to promote continuous improvement. PROFESSIONAL EXPERIENCEInfosys Ltd Peapack, NJ Aug 23 to CurrentPrincipal Solution ArchitectProject: Pfizer, Inc - ARIES Provide PV subject matter expertise for enhancing and solutioning the Drug Safety data reporting process. Collaborate with business stakeholders and project teams to build a Pega-based Workflow system for automating Aggregate Reports requests, authoring, reviewing, and distribution processes. Understand technical design specifications, and infrastructure and liaise with project manager, business analysts, and technical teams to ensure the solution approach aligns with business requirements. Analyze complex processes, workflows, and requirements and translate them into effective solution designs. Leverage industry standard best practices and principles regarding solution design and implementation. Daiichi Sankyo, Inc. Basking Ridge, NJ Jun 15 to Jun 23 Associate Director (Data Management & Analytics, Clinical Safety and Pharmacovigilance) Projects: Argus Safety implementations (GSDB) Reporting & Analytics Tool (PVC, PVR, ConvergeHealth Safety, Argus Insight) implementations Novella-Ambit Biosciences and Cosette Pharmaceuticals, Inc., Data Migration Robotic Process Automation BOT implementation Pfizer, Organon and Merck E2B implementations as per PVAs Medidata RAVE Safety Gateway implementation CSPV Volume Metrics Power BI Dashboard/CSPV Sharepoint Trackers SNL Trifecta Safety Vigilance Integration EUDRA Vigilance Go-live DSD merger and CRO Unification Master Data Management Member of GMT organization and Global Governance committee for GSDB maintenance and decision-making. Ensure maintenance of safety database to be in compliant with the regulatory requirements, industry standards and internal procedures. Member of Global Working Team and PMO to establish project governance and work closely with Program Managers to support process/project management activities. Business Owner for various local/global initiatives, managed project scope, cost, goals and deliverables, contributed and coordinated to the continuous development, maintenance and project implementations. US Business Leader for determining requirements for safety database upgrades, implement computerized tools, define system requirements, data entry conventions and processes for global harmonization through collaboration with CSPV senior management, Case Management, Clinical Safety, Regulatory Intelligence- Strategic Partner Management, Clinical Study Startup, Quality & Compliance teams, external vendors and Global CSPV/Informatics groups. US Local Process Manager for global database team, analyze the scope and implementation of configuration updates to IPOS Systems (Integrated Pharmacovigilance Operating Systems). Suggest alternate solutions to provide technical recommendations for complex changes. Peer review and manage documentation and implementation of Change Request supporting documents. US Local Validation Lead for approving US-initiated validation and configuration processes, timelines, reviewing and signing off on validation deliverables. Handle PV Data Management and Analytics works, review and approval of data report requests for all the functions in PV Operations - QCT, CSS, Case Management and Clinical Safety/Aggregate reports. Routinely review Global Safety Database Processes for CSPV SOPs/SOIs and implement process improvements to enhance efficiency and productivity. Collaborate with CSPV safety stakeholders to proactively identify and develop safety search strategies for ongoing safety surveillance activities and approve ad-hoc reports in support of CSPV, other departments, regulatory inspections/audits. Act as CSPV-DBMA representative during safety regulatory inspections. Provide oversight and guidance to external implementation vendors in support of IPOS systems. Mentor colleagues in processes, systems and responsibilities. CAPA Lead for IPOS systems, provide expertise to author QE and suggest adequate corrective/preventive measures by systematic investigation and record root cause analysis of identified problems/risk preventing recurrence. Business member for implementing a software robot to leverage technology to streamline the process of managing items received in the CSPV mailboxes and reconciling cases received from DS Sponsored studies and other adverse event reports received by CSPV from Daiichi Sankyo partners. CSPV business member for the RSG Project which allows the automated transmission of SAE information from RAVE EDC to IPOS when reporting from sites to CSPV. Business lead for implementing a Power BI dashboard to visualize and analyze the Case Volume Metrics data and Compliance data for case submissions to LP, HA and ROW submissions. Systems Lead for streamlining the Argus Safety configurations for CRO Unification Projects by retiring the CROs and assigning Case Processing activities to one strategic partner. Deloitte New York City, NY Jul 13 to Mar 15Safety Systems Lead/SMEProjects: Daiichi Sankyo Arisg to Argus 6.x Safety Data Migration Pfizer Inc. - Lyrica Questionnaire project Eli Lilly - Argus 7.0.3 upgrade Lead verification efforts of Argus data migration work stream and involved in planning, design verification strategies, define acceptance criteria, select test methodology, verify test execution and review results. Interpreted the functional, non-functional requirements and assisted in providing input, reviewed and participated in the development of user documentation. Constant collaboration with various teams to address potential issues/risks and meet deadlines. Prepared and published weekly status reports of the project progress, contributed to updating the project plan and presented it in team meetings. Lead key stakeholder analysis process, meetings and interacted with project stakeholders to elicit and document business requirements for Lyrica questionnaire project. Conducted JRD sessions, elicit business requirements; analyze details to uncover cross-functional implications. Prepared presentations for workshops and documented keynotes/decisions for Argus upgrade discovery phase as part of business configuration work stream.Pfizer Inc. Peapack, NJ May 11 to May 13Project Manager (Empirica Signal Detection)Projects: Empirica 7.3 Upgrade Project Empirica Support and Maintenance Lead the project planning and implementation of Empirica Upgrade project. Developed project plan, defined project tasks, documented business requirements, resource requirements, scheduled project timelines, provided direction and support to upgrade project team. Responsible for managing development activities, system testing, preparing UAT scripts, test summary report and ensured project deliverables are completed within time and scope. Worked with project stakeholders, vendors and end users to gather business requirements for related CCR and authored Maintenance Release Plans for various application configuration changes. Conducted meeting with Business and presented reports defining progress of CCRs, problems and solutions. Tracked key milestones and adjusted release plans accordingly. Maintained disaster recovery plan and participated in DR exercises where applicable. Monitored quality assurance measures to produce and maintain Key Performance Indicators (KPIs) around the testing performed within the team. Ensured coordination between offshore team and onshore operations. Aris Global LLC. New Jersey Mar 09 to Mar 11IT Implementation ConsultantClients: Hoffmann-La Roche Ltd., Forest Laboratories/Eisai, Celgene, Array BioPharma Intrasphere Technologies Inc. New York City, NY Apr 07 to Dec 08 Business Analyst/Oracle DeveloperProjects: Pfizer Inc. - ARISg to ARGUS Safety Data Migration J&J Pfizer Consumer Healthcare - Legacy database migration to Arisg Millennium Pharmaceuticals - ARGUS UpgradeGE Commercial Distribution Finance Chicago, Illinois Mar 06 to Mar 07 Oracle DeveloperProjects: CLS (Credit Link System) ECS (Enterprise Credit System) EDUCATION Masters in Computer Applications, Osmania University, India Bachelors in Computer Applications, Osmania University, India |
