SUMMARY

• Over fifteen years of progressive experience in Project Management, System Implementation, Upgrades and Support, Validation, M&A etc. in the pharmaceutical and biotechnology industry.
• Successfully managed full lifecycle of GXP regulated R&D business applications from inception through implementation, support, ongoing enhancements and decommissioning while ensuring compliance with the FDA regulations and the PMO best practices.
• Proven ability to understand User Requirements and develop appropriate software solutions with hands - on approach.
• Well versed in Mergers and Acquisitions - part of the PMO for several acquisitions for integrating R&D Applications.
• Proven expertise in developing project charter and scope, oversee all aspects of project, plan and direct schedules and budget.
• Set and maintain client expectations on scope, timeline and budget while building a collaborative and constructive relationship with client teams.
• Provide visibility to team impediments and risks and assist in eliminating them.
• Track and report status and other metrics against goals on an ongoing basis.
• Facilitate sprint planning, daily stand-ups, retrospectives and task estimation.
• Assist product owners and teams in release planning and maintaining the release/sprint backlogs.
• Maintain a harmonious relationship with all stakeholders to ensure smooth delivery of the project
• Broad experience in multiple R&D functional areas with exposure to a wide range of applications:
• Pharmacovigilance: Argus Safety Suite, PV Monitor, E2B(R3), Empirica Trace
• Regulatory Affairs/Quality Assurance: Veeva Vault, Veeva RIM, Veeva Promomats, docuBridge, Virtual Publishing, Trackwise etc.
• Clinical and Laboratory Informatics: Siebel CTMS, Watson LIMS, STARLIMS, Pipeline Pilot, Tecan, Pharsight
• BI & Reporting: Cognos, QlikView, Tableau, Advanced Dashboards and macros in Excel
• RPA: Automation Anywhere
• Well versed in Software Development Lifecycle (SDLC) and System Validation Lifecycle (SVLC).
• Expertise in developing, documenting and executing the various components of the Validation Package.

PROFESSIONAL EXPERIENCE

Confidential, Northbrook, IL

Project Manager

Responsibilities:

• Project Manager for multiple projects concurrently for R&D Applications.
• Define and understand client needs and lead the analysis, design, and implementations of work stream solutions on projects while anchoring all outputs to agreed project scope, objectives, deliverables, and timelines.
• Perform routine project management activities, status reporting, stakeholder management, and workload and resource distribution.
• Develop project plans, project charter, Business Cases, RFPs, identify resource requirements and assist in vendor selection.
• Oversee the development of validation deliverables and manage the relationship with QA to ensure that the systems are developed and implemented in accordance with the regulatory requirements.
• Co-ordinate with offshore teams to manage Support activities.
• Recently developed and implemented novel, custom and COTS, validated R&D IT systems to meet compliance requirements and improve process efficiencies:
• Data migration projects (both inbound and outbound).
• PM for work streams for implementation and upgrade of Argus Safety, Veeva Vault Suite, docuBridge and Virtual Publishing.
• Automation of PV Case Intake using bots based on the Automation Anywhere™ platform.
• Integrate Argus with Documentum to store case attachments and reduce database size.
• In-house developed system to manage the lifecycle of Safety Data Exchange Agreements to address CAPA’s
• Dashboards for inbound and outbound compliance for License Partners and CRO’s, Case Processing KPI’s, Safety Issues, Distribution of aRMM’s etc.
• Set-up E2B exchange with Health Authorities and License Partners and develop custom E2B Profiles
• Lead several change control and data migration projects for in various roles as Project Manager, Lead Developer, Business Analyst etc.
• Develop and validate numerous PL/SQL scripts for cleaning up data anomalies resulting from migrated data.
• Implement the internal Astellas customizations for migrated data.
• Support Business Users, provide Audit Support and develop queries to support complex ad-hoc reporting requests.

Confidential, Cambridge, MA

Validation / Support Lead

Responsibilities:

• Core member of the PV Informatics team and the PMO for the $ 3.6 million project for implementing and validating Oracle Argus Safety and Argus Insight.
• Comprehensive understanding of the Pharmacovigilance business process, Argus Safety System Configuration and Reporting, and Argus Safety schema.
• Played a key role in developing the system configuration for the Argus Safety system and Argus Insight in close co-ordination with the business users and vendor.
• Configured the Argus Safety system with respect to Case Form Configuration, Product Families, Products, Licenses, Reporting Rules, Studies, Advanced Conditions, Workflow, Security, Field Validations etc.
• Provided status reports to senior management and negotiated with respect to time lines, resource allocation, issue management, task prioritization etc.
• Effectively led the requirement gathering process for custom reports and views, and co-authored the Requirements Specification.
• Authored Risk Assessment, Validation Plan, Test Plan, Traceability Matrix, Validation Summary Report etc.
• Led a team of six Validation Analysts for the authoring and execution of OQ’s and PQ’s within the assigned timelines.
• Managed the relationship with the Computers Systems QA Group, obtained and responded to QA Reviews and ensured timely approval of the validation deliverables.
• Contributed substantially to the development of Training Plan, Training Materials, SOP’s etc.
• Post-implementation, manage the Support Desk and provide level II production support to approximately 600 end - users globally in US, EU and Asia.
• Analyze regulatory and business changes and subsequently develop solutions.
• Manage Change Controls and implement system modifications / enhancements.
• Conduct End User Training and System Administration Training for new hires.
• Provide support for ad-hoc and periodic reporting.
• Support MedDRA and WHO Drug Dictionary upgrades.
• Analyze newer versions for the Argus Safety Suite and proactively build consensus with the business users for system enhancements / modifications in alignment with the Pharmacovigilance Informatics Roadmap.
• Assisted in the development and validation of a Reporting Portal based on SharePoint and Spotfire Author and execute test scripts and other validation documents, co-ordinate and respond to QA Reviews.
• Assisted with the validation of Siebel CTMS.

Systems: Argus Safety, Argus Insight, Oracle, SQL, Toad, MedDRA, Spotfire, Qlikview, Siebel CTMS etc.

Confidential, Thousand Oaks, CA

Project Manager / Validation Lead

Responsibilities:

• Project Manager for the Research Informatics team for implementing medium scale projects (400k - ~ $1 million) viz. PK Reporter S-PLUS and Pipeline Pilot for automating PKDM workflows.
• PK Reporter S-PLUS: This is a statistical application leveraging S-PLUS and the PKDM Datamart for automating the generation of tables and graphs and calculating summary statistics for Pharmacokinetic / Toxicokinetic Reports.
• Led the development and implementation of the PK Reporter S-PLUS as Project Manager.
• Created and managed Project Plans, Budgets etc.
• Provided periodic updates on the Project Status to the Steering Committee.
• Actively led Project Meetings with PKDM and vendor for developing business requirements, identifying critical roadblocks and suggested suitable solutions.
• Collaborated with the PKDM Scientists for understanding User Requirements and developed the system in accordance with GxP and 21 CFR Part 11 regulations.
• Served as the Lead Validation Analyst and mentored two validation analysts for preparing the Validation Package.
• Created SOPs, Training Materials and Solution Representation.
• Implemented and validated the custom developed Pipeline Pilot protocols.
• Implemented Change Controls for the Tecan EVO validated instrument and filed RFCs.
• Developed the system architecture including identifying suitable infrastructure and creating user groups and service accounts with appropriated access levels.
• Integrated the Pipeline Pilot protocol with the Tecan EVO scripts for automating sample dilutions.
• Provide guidance on quality issues that affect the integrity of the data or the system.
• Authored and executed the Validation Package.

Systems: S-PLUS, Pipeline Pilot, Tecan EVO, Pharsight Knowledgebase Server, NuGenesis SDMS (Electronic Lab Notebook), Watson LIMS