Project Manager - Drug Safety

NIRANJAN SRINIVASAN

**** ***** *****, **********, ** -07095

• CELL – 848-***-****• EMAIL: ********.**********@*****.***

PROFILE

 Valuable experience of 13 years in project management, implementation of both regulated and non regulated systems, requirements analysis, design, testing, customer support and developing drug safety related data warehousing, clinical and regulatory reporting applications using various development tools.

 Highly self motivated, professional with creative ideas, zeal to excel and proven track record of having successfully completed and timely delivered projects, with an extensive knowledge of SDLC.

HIGHLIGHTS

 Currently consulting as Project Manager, drug safety systems at Pfizer Inc since Dec 2007. Manage various project streams, conduct technical feasibility analysis; function as integrator between business needs and technology solutions, responsible for design and implementation of technology-enabled custom business solutions supporting both legacy drug safety system ARISg and new system Argus. Currently supporting the Argus suite of applications.

 Worked as Business Analyst / Senior implementation consultant, executing the complete SDLC of the project starting from gathering user requirements, develop, install, configure the application, validate and move the application into production and provide post production support. Also constantly coordinated with off-shore teams to monitor, debrief the business requirements and manage the deliveries.

 Possess domain knowledge on drug safety systems, focusing on implementing various software solutions like ARISg, Argus at various pharmaceutical companies to cater to the drug development life cycle.

 Responsible for design, development and managing a data warehousing product called SafetyMart.

 Ably maintained, validated, implemented, safety data management applications and worked on various warehousing tools.

 Successfully handled several data migration projects leading the Expert services division at Arisglobal.

 Working knowledge of ClinTrace and Informatica.

Summary of Professional career:

 1+ year as Project Manager, Development Informatics division -Pfizer supporting drug safety systems like ARISg and Argus.

 3+ years as Business Analyst / senior implementation consultant, implementing various drug safety software solutions like ARISg.

 3+ years in project management, design and development of data warehousing product.

 2+ years in software development and testing of drug safety products like ARISg.

 2 years in training, project and process management.

 2 customer support assignments at Europe (3 months) & USA (6 months).

 1 year in space/concept selling.

Technical Skills:

Hardware used: Intel based platforms

Operating system: Windows based and fundamental UNIX.

RDBMS: ORACLE 8i, 9i, 10g, (SQLPLUS, PL/SQL)

Report tools: Crystal Reports 8.5, Impromptu 7.0, Business Objects 6.5, XI.

Languages: C/C++, Java (fundamentals, core Java)

GUI tool: Open Interface

ETL tools: Informatica

OLAP tools: Business Objects, Cognos, Oracle Warehouse Builder

Design tools: Rational Rose, Erwin

Project management

tools: MS Project, Visual Source Safe, Install Shield 5.0

Professional Experience:

Resource logistics Inc. USA (Consulting at Pfizer Inc) - since Dec 2007

Currently consulting as Project Manager, drug safety systems at Pfizer Inc supporting the Development Informatics division.

 Successfully implemented safety solutions by coordinating with business users to gather and formalize business requirements and transform these to functional specs and then design, co-ordinate and implement technology-enabled custom business solutions for both legacy system ARISg and the current system Argus.

 Ably manage and develop several change controls / patches to either fix issues with data migration from ARISg to Argus or to address any business requirements.

 Owned and manage the thesaurus management system (TMS) interface which is a bridge between Argus and TMS system to sync the dictionary terms between the two systems.

 Actively involved in devising strategies for building various environments and refreshing with migrated data and common configuration data using a tool to copy configuration from one given environment to other and speed up refreshing process.

 Co-ordinate between business users and vendor to troubleshoot issues, analyse enhancements and provide optimal business solutions. Also co-ordinate the release, delivery of patches/upgrades and deployment in both validation and production environments for Argus & Insight application. Also involved in implementing the Argus including installs, environment setup, analysis, transformation of source data and the transition from ARISg to Argus.

 Acting as technical analyst for Argus Insight application and currently primary point of contact for trouble shooting technical issues with Insight. Also developed custom reports using business objects and modified existing COTS reports to meet updated business requirements.

Arisglobal LLC, USA -Mar 2005 to Dec 2007

Played the role of Business Analyst / senior implementation consultant handling various software implementations of safety solutions across several pharmaceutical companies

 Manage multiple implementation projects and provide technical/project guidance.

 Gather and review requirements with customers and formalize user requirements.

 Successfully implemented several safety solutions like ARISg, AgXchange and SafetyMart at various pharmaceutical organizations like Daiichi-Sankyo, APP, Takeda, IVAX, Human Genome, 3M, United Therapeutics and Forest Labs.

 Implementation process involved gathering requirements, installation, development, validation and training the business and IT users on safety systems and technical training on OLAP tools like business objects.

 Develop universes and reports using business objects and Oracle PL-SQL to be integrated with regulatory applications.

 Successfully managed/implemented several data migration projects from legacy safety systems to ARISg.

 Co-ordinate the requirements and delivery, between customer and offshore development team.

 Validate safety systems based on FDA regulations and help customers go-live using phased execution from development to validation and finally into the production environment.

 Working with sales team on pre-sales activities and conducting various product demos.

 Provide product and technical trainings to both customer and in-house resources.

 Conducted market study on enhancements for SafetyMart and successfully implemented the product across several customers like Daiichi Sankyo, 3M and Health Canada.

ArisGlobal India Pvt. Ltd. (SysArris Software Pvt. Ltd.) -Dec 1998 to Feb 2005

 Played the role of project lead and was responsible for the complete lifecycle of data warehouse product SafetyMart from project management, market study, analysis, design to development, release of the product from scratch. Initially was the sole member in the design, development and managing SafetyMart project and later led a team of 8 members to develop, maintain and implement enhancements to the product.

 Worked as Team Leader, leading a team of 6 and handling the development activities of the Expert services division, a division responsible for handling all data migration projects, merge multiple legacy databases, custom requirements like screen customization, configuring custom workflows, developing custom reports. Was initially selected as a programmer for launching this division and later lead the expert services division consisting of 6 team members.

 Worked as testing resource, testing various safety applications, data migration code and writing test scripts, test plans and quality plans.

 Major clients for data migration projects executed by me, include BI (US), Maxim(US), Grunenthal (Germany) , Merck (Germany, France), Medeva (UK), Leo(UK), Orion (Finland).

 Successfully handled customer support assignments at ArisGlobal, Germany and USA. The main goal of the assignment at Germany was to provide support on ARISg to several customers located around Germany. The main goal of the assignment at USA was to conduct a market study on SafetyMart and design the new features of the product accordingly and also to provide support on SafetyMart to US customers.

Novel Software Systems -Oct 1996 to Nov 1998

 Started as a Trainee Programmer and served as Asst. Project coordinator till Nov '98.

 Additional role of ‘Course - In – Charge’ included responsibility for

o Driving the academics activities towards achieving ISO-9002 certification.

o Monitor the class, lab faculty and SOPs maintained.

Tata-Donelley -Mar 1995 to Mar 1996

 Worked as Sales Executive of space selling for Tata-Donelley yellow pages

 Was selected to be part of the team for launching the Exporters division of yellow pages.

EDUCATION

Course Year of Pass

Oracle 9i and Data Warehousing 2004

Master of Computer Applications

[University of Madras] 1999

Higher Diploma In Software Engineering [Aptech] 1998

Bachelor of Science[Physics, Mathematics & Electronics], Bangalore University 1994

Bachelor of Arts [Hindi]

Mysore Hindi Prachar Sabha 1996

Training undergone:

• Oracle 9i, Data warehousing, Project management and Novell Netware 4.1.

Achievements:

• Achieved Excellent Performer award for successfully executing implementation projects at Arisglobal, US.

• Achieved Good Performer Award for data migration projects at ArisGlobal India Pvt. Ltd.

• Usually a candidate for the team, starting a new venture in the organizations worked.

• Stood first for the study center in both I & II semester at Aptech jayanagar during my software engineering course.

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