SUMMARY

• With over 29 years of consulting experience across multiple industries, and 15 years focused exclusively on life sciences, I bridge the gap between IT and PV
• The first 14 years were exclusively in IT
• Well versed in all phases of the project life cycle
• The last 14 years have been in drug safety and surveillance activities
• Managed large - scale projects including big data migration projects and ARGUS implementation projects
• Experience with all phases of SDLC cycle
• Proficient in writing Business Requirements, Test Plans, UAT testing
• Project Manager for Data Migration and System Implementation Projects
• Safety Signal and Risk Management Implementation Projects
• RFI, RFP, PV Vendor selection and Transition activities
• PVA agreements and contracts
• Business Continuity and Disaster Recovery Specialist
• Extensive knowledge in BI tools including Hyperion, Business Objects and Cognos

PROFESSIONAL EXPERIENCE

Senior Business analytics Report Developer

Confidential

Responsibilities:

• Senior technical lead for US-based analytics development team supporting Oracle AERS
• Business analysis and requirements verification supporting PV/safety system requests
• Development of PV/Safety regulatory-analytic reports, custom requests in Oracle DB utilizing baseline templates, custom SQL queries, and Business Objects
• Report output verification and validation
• SOP authoring for business, developer, and validation processes
• Guidance and support to business user community
• Mentoring to junior developers
• Change control management and impact analysis

Technical Consultant

Confidential, NJ

Responsibilities:

• Administrator for ARGUS Safety, ARGUS Insight and Spotfire applications
• Provided guidance and support to the business users for the above applications
• This included answering user questions, doing change controls and making sure a proper impact analysis is done for all issues

Senior Consultant

Confidential, NY

Responsibilities:

• Successfully wrote and got approval on a Business Continuity Submission Job Aid for Biogen. This involved working with the Biogen Submissions team and gathering information on ALL regulatory agencies for the document
• Designed and deployed surveys to all Allergan Affiliates to identify local and systemic risks. Collected and analyzed responses, included sending out reminders to achieve full participation. This process was done for 3 separate surveys - Pharmacovigilance, Medical Information and Healthcare Compliance. Reviewed PVA agreements with the affiliates
• Reviewed and commented on 30 + SOP’s for the Glenmark Argus Safety and Argus Insight project. This involved SOP’s from Oracle, Sciformix, Glenmark and Navitas. Wrote five Integrated SOP’s to incorporate multiple stakeholders’ SOP’s
• Reviewed RFP for Argus Implementation project for ARIAD. Helped in shaping and preparing the proposal. Presented the proposal to ARIAD management
• Presented Business Continuity Planning findings and insights to a global network of PV technology specialists in London and New York

Business Analyst/Project Manager

Confidential, CA

Responsibilities:

• Managed the implementation of ARGUS 7.0.4 in Confidential . This included ARGUS Safety and Insight. This involved integrating three databases into one database
• Data migration required both E2B and manual data migration
• This was a global database implementation and included EU and the US
• This system successfully went live on November 11, 2014 within six months of initiation
• Managed the whole process from RFI, RFP, Vendor Selection and negotiation and finally overseeing the implementation of the system
• This was a CLOUD based solution using the SaaS model
• Involved in review and writing PVA agreements with vendors
• Also participated and oversaw UAT testing
• Acted as Relationship Manager for both the old (ARISg) and new (Argus), to make sure the system was functioning smoothly
• Supported the DSSS/PM in EU/US Drug Safety database working group
• Conducted Smoke Testing on ARISg and ARGUS system
• Served as Database Super-user to contribute to and support creation of global drug safety database validation, implementation, training, strategy and ongoing global use
• Assisted with creation and implementation of Drug Safety operational processes and tracking systems
• Created Business Impact Analysis (BIA) document for the Drug Safety Group

Consultant

Confidential, NJ

Responsibilities:

• Developed Business Objects (BO) reports for the above client
• Report was based on the Adverse Safety data in AERS, sorted by SOC and providing case details and other pertinent information
• Used Toad to populate the data in the tables and used Business Objects to retrieve and create the reports

Business Analyst/Project Manager

Confidential, PA

Responsibilities:

• Primary point of contact to Cardiovascular/Coagulation and Psychiatry Therapeutic Area Lines
• Worked using ARGUS Safety and ARGUS Insight
• Worked closely with the TA Head and Authors to drive project needs and timeframes
• Ensured the delivery of clinical trial and safety data tables for inclusion in various worldwide regulatory submissions and responses
• Developed reports for PSUR, DSUR and SUSAR reporting
• Used SPOTFIRE to analyze data and produce reports and charts
• Developed PFAST BO reports based on Adhoc requests which contributed to FDA, EMEA and individual medical boards
• Extensive use of SQL Plus and Business Objects reporting tool
• Participated in developing and performing User Acceptance Testing (UAT) in ARGUS
• Supported Audits and Inspections related to data requests
• Worked with Business Objects in an Oracle ARGUS environment
• Extensive use of SQL
• Managed Data Migration and integration activities for merging Wyeth and Pfizer databases
• Managed the implementation of Signal Detection tool in Wyeth
• Liaised with vendor, business stakeholders and technical groups that defined and gathered business requirements for the project
• This was successfully implemented in year 2009
• This project was developed using Drug Logic as the vendor and Qscan was the product developed for Signal Detection
• This product is still a major player in the Signal Detection world. Overall project manager for all phases of the Vendor selection cycle
• Business Analyst and Project Manager for MedDRA upgrades, Global Data Management and various other projects which met FDA requirements
• Worked on Divesture of Products
• Identified cases which needed to be transferred to the acquiring company and ensured they were properly managed
• Supported Audits and Inspections related to data requests by FDA, EMEA and any other regulating body
• Participated in developing and performing User Acceptance Testing (UAT) as required
• Developed a Business Continuity Plan for the division
• Participated in Disaster Recovery exercises and made presentation to the top management
• Participated and wrote high level requirements, RFI and RFP proposals
• Involved with all the phases of the project as a Project Manager
• Projects ranged from two months to two years
• Used Microsoft tools to for resourcing, planning and tracking of projects to insure all deliverables (data specifications, dataset mapping, tables and reports) were executed in the required time frame
• Extensive use of Hyperion and SAS datasets
• Used Agile Project Management techniques to deliver the project to the user
• Development of Hyperion BRIO reports based on Adhoc requests
• Extensive use of SQL Plus and ACTUATE reporting tools
• Worked with physicians and other health personnel to manipulate data and write reports