SUMMARY

• Over fifteen years of progressive experience in Project Management, System Implementation and Support, Validation, Test Planning and Technical Writing in the pharmaceutical and biotechnology industry.
• More than ten years in PV Informatics with extensive experience in Argus Safety System Implementation and Upgrades, Data Migrations, Reporting, System Support, Project Management and Validation.
• Extensive experience in implementation, project management, data migration, validation, support and business analysis of Argus Safety, Argus Insight and other PV Solutions in a global, matrixed environment.
• Comprehensive understanding of PV business, Case Processing, Expedited and Periodic Reporting and Argus Safety Data Model with proven expertise in PL/SQL and SQL.
• Proven ability to understand User Requirements and develop appropriate software solutions with hands - on approach.
• Excellent project management and analytical skills with ability to function in a fast paced, team-oriented and continuously changing environment and consistently meet deadlines and budget with a keen attention to details.
• 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 including Validation Plan, Risk Assessment, IV, OV and PV, Traceability Matrix, Validation Summary Report, SOPs / WPs, Deviation Reports,

TECHNICAL SKILLS

Applications: Argus Safety v7.x - 8.x, Argus Insight, Empirica Signal, Veeva Vault, Toad, SQL Developer, JIRA, Cognos, QlikView, SharePoint, Siebel CTMS, Documentum, TrackWise, Citrix, Pharsight Knowledge Base Server, Pipeline Pilot, S-PLUS, Sigma Plot, Spotfire, Tidal Scheduler, MS Visio, MS Project etc.

Reporting Tools: Qlikview, Cognos, Spotfire

Databases: Oracle, SQL Server, MS Access

Languages: SQL, PL/SQL, VB

LIMS: Watson LIMS, STARLIMS

PROFESSIONAL EXPERIENCE

Confidential

Project Manager / Lead Developer

Responsibilities:

• Develop novel, custom, validated PV systems to meet compliance requirements and improve process efficiencies:
• PM for Argus Interfaces, WPD’s and Axway Upgrade for the Argus Safety v8.1.1 Upgrade
• SME for internal customizations for the Astellas Argus Safety System
• Lead several change control and data migration projects for supporting the global Astellas Drug Safety System 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
• Co-ordinate with off-shore team to manage Argus Support activities
• Set-up E2B exchange with Health Authorities and License Partners and develop custom E2B Profiles
• 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.
• Manage RFP’s, create Business Cases, Project Charters and assist in developing PV technology roadmap
• Support Business Users, provide Audit Support and develop queries to support complex ad-hoc reporting requests.
• Upgrade the WHO Drug and MedDRA Dictionary.
• Support cross-functional projects with RA and QA

Confidential

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 Spofire for the PV work stream
• Author and execute test scripts and other validation documents, co-ordinate and respond to QA Reviews
• Draft and revise SOPs and Training Materials

Environment: Argus Safety, Argus Insight, Oracle, SQL, Toad, MedDRA, Spotfire, Qlikview etc.

Confidential

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.
• 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.

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