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Safety Manager

Location:
Plainsboro Township, New Jersey, United States
Posted:
September 27, 2019

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Resume:

Pawan Kumar Sharma

916-***-****(Mobile) adagso@r.postjobfree.com

PROFESSIONAL SUMMARY

PMP Certified (October 2011) with 19+ years of IT experience

* *** ********** ** **** Safety products (Oracle Argus Safety/ Oracle Argus Insight/Empirica Signal Detection) and part of development team in Relsys and Oracle India

Manage and Lead development team for Argus Safety Service packs and Argus Insight 6.0

Experience in Oracle Argus Safety 4.1 (Single-Tenant) to 7.x (Multi-Tenant) (Case Processing, Workflow, Configuration, Interfaces, Console, AG Service, ESM modules)

Extensive experience with E2b reports including and not limited to E2b Plus, extensions and adhoc/aggregate reporting

In-depth knowledge of Argus Safety technical architecture and database modeling

Experienced in Business Configuration (Product/Study/License, Reporting Rules) and System Configuration in Argus Safety Console

Experienced in configuring AG/ESM/E2B (R2/R3) profiles (with customization) and Axway Interchange gateway for electronic submissions using AS1.0 and AS2.0 protocols

Managed Application Support and Infrastructure support with Vendor management for Argus Safety

Experienced in MedDRA/WHO loading and up versioning

Experienced in Cognos integration with web application using Cognos SDK in Argus Insight 7.0

Expertise in Oracle Empirica Signal Detection 7.3

Experienced in authoring/and executing test cases (OQ, IQ and PQ) manual or automated tool (HP Quality Center)

Strong experience in windows/web applications Design, Development and Maintenance using ASP, VB 6.0, ASP.NET, ADO.NET, C#, VB.NET, JavaScript, AJAX, IIS, XML, Oracle 9i/10g/11g and SQL Server 2000/2005.

Strong experience in client interaction with onsite experience in USA, Japan, Singapore and Holland.

Experience in High Level and Low-level Design Architecture using UML (use case identification, use case diagram, Sequence Diagrams, Class identifications and class diagrams, activity diagrams), along with Data base Designing.

TECHNICAL SKILLS

Technologies : ASP, VB 6.0, ASP.NET, C#, VB.NET, ADO.NET, ASP, AJAX, WSDL,

XML, SOAP, XSD, XSLT

Web Development : HTML, DHTML, XHTML, CSS, jQuery, Java script

Languages : Python, C#, VB.Net, VB 6.0, PL/SQL, Sql plus, TSQL

Distributed Technologies : COM, DCOM, MS Web services, XML, Remoting, MSMQ

Operating Systems : Windows - 2000/NT/XP/2000/2003/2008, HP-Unix 10.0

Databases : Oracle 8i/9i/10G/11G, SQL SERVER 2000/2005

Web Server : IIS 4.0/5.0/6.0/7.0, Apache Tomcat

Reporting Tool : Crystal Reports 8.5, Cognos 8.4

Version Control : Microsoft Visual Source Safe, SVN, SOS

Design Patterns : MVP, MVC, Abstract Factory, Facade, Singleton, Observer

3rd Party Libraries/Tool : NumPy, Pandas, MetplotLib, Seaborn, Tableau

ML Algorithms : Linear/Logistics Regression, SVM, KNN, NLP

PROFESSIONAL EXPERIENCE

Argus Safety

Client Name: Pfizer

Organization: Resource Logistics

Environment: Argus Safety 7.0.7

Role: IM Lead (Onsite)

Duration: Jan 2018 – Till Date

Project Description

Supporting Oracle Argus 7.0.7 Business configuration in Pfizer. Support scope consist Reporting Rules, Code Lists, eCBD and managing change controls day to day.

Responsibility:

Managing change controls for Argus Safety (Business Configuration, E2B)

Managed and automated eCBD (electronic configuration baseline documents)

Managed Reporting Rules reverse engineering (queries to populate excel) and provided for Audit requests/or Business

Empirica Signal Detection Implementation

Client Name: United Therapeutics

Organization: Resource Logistics

Environment: Empirica Signal Detection 7.3 / Argus Safety 7.0.5 / Argus Mart / ODI

Team Size: 6

Role: Technical Lead/SME (Onsite)

Duration: Apr 2018 – Aug 2018

Argus Safety

Client Name: Otsuka

Organization: Resource Logistics

Environment: Argus Safety 7.0.4

Team Size: 15

Role: Safety Data Manager (Onsite)

Duration: Oct 2015 – Jan 2017

Project Description

Supporting Oracle Argus 7.0.4 system in Otsuka. Support scope consist configuration/enhancement and handling day to day issues.

Responsibility:

Managing change controls for Argus Safety (Configuration, Interfaces and E2B)

Managing Argus infrastructure

Handling TransformPV tool (eMDR - E2B R2-R3 transformation engine), developed by Vitrana

Handled Argus Safety Performance issues

Empirica Signal Detection Support

Client Name: Pfizer

Organization: Infosys Ltd.

Environment: Empirica Signal Detection 7.3 (PL/SQL, Bash Shell Scripts) / Argus Safety 4.2, 7.0.3.004

Team Size: 30

Role: Technical Lead (Onsite)

Duration: Mar 2013 – Oct 2015, Jan 2017 – Jul 2017 (From Resource Logistics)

Project Description

Supporting Oracle Empirica Signal Detection 7.3 and Argus 4.2/7.0.3 system in Pfizer since March 2013. Support scope consist configuration/enhancement and handling day to day issues. Pfizer has out of box customization that integrates clinical and safety data from different source systems to Pfast (Pfizer custom Database ware house). Empirica Signal Detection uses Pfast dataware house as source system for company database and generates signals (using Signal Preparation Job).

Responsibility:

Day to day co-ordination with Client

Managing technical change controls for Empirica Signal Detection and Argus Safety (Configuration, Interfaces and E2B)

Monitor/Debug/Fix weekly Empirica ETL/Signal Preparation Job (SPJ)

Implemented enhancement (custom term and updated SPJ code) for Signal Views in Empirica

Single Point of contact for Empirica

Member of Argus 7.0.3 Deployment team (AG Service/ESM Service configuration, E2B Profiles setup)

GSIP Reporting

Client Name: Merck Research Laboratory Technology

Organization: Cognizant Technologies

Environment: Argus Safety 6.0 (Safety and DLP), Cognos 10, Spotfire

Team Size: 10

Role: Project Manager (Onsite)

Duration: Mar 2012 – Mar 2013

Employer: Cognizant Technologies

Project Description

Merck Research Laboratory Information Technology has undertaken an initiative to outsource the development and testing of ad-hoc/custom reports, building custom advanced conditions and execution of front end reports in order to effectively service/support the business unit to respond to Health Authority enquires, audit, adhere to aggregate and expedites reporting requirement.

Responsibility:

Day to day co-ordination with Client

Project Planning

Argus SME

DMWT (Clinical Supply)

Client Name: Fisher Clinical Services

Organization: Cognizant Technologies

Environment: SQL Server 2008, SSIS, Team Foundation Server, XML

Team Size: 10

Role: Validation Lead (Onsite)

Duration: Nov 2011 – Mar 2012

Employer: Cognizant Technologies

Project Description

FCS has requested Cognizant to implement an in-house DMWT at FCS, containing data from Cenduit SIRT and the FCS inventory or transferring of data to Novartis (FCS’s Client Pharmaceuticals that has requested the end-to-end visibility of clinical supplies). Currently there is no single system which can provide data extracts to NOVARTIS for drug accountability from patient level to drug/product substance. DMWT is to provide information not only for drug accountability but also for other data extracts related to the studies carried out for NOVARTIS.

Responsibility:

Developed Validation Plan/Test Strategy and co-ordination with Client.

Offshore validation team handling

Reviewed OQ scripts

Developed IQ script

PRIMO

Client Name: November Research Group

Organization: R-Systems Inc.

Environment: XML, XSLT, Oracle 11g

Team Size: 4

Role: Developer

Duration: Jul 2011 – Oct 2011

Employer: R-Systems Inc.

Project Description

PRIMO is streamlined data capture system for adverse events, pregnancy registry, and product complaints. PRIMO complements and extends your existing pharmacovigilance system by providing a unified data intake mechanism from your call centers, safety data management organizations, affiliates and partners.

Responsibility:

Synched the data entry report with the user interface.

Developed audit log report

Installation and IQ for Argus Safety 7.0 multitenant

Wave III

Client Name: Genzyme (Boston)

Organization: R-Systems Inc.

Environment: Cognos 8, Oracle 10g

Team Size: 3

Role: Developer

Duration: Mar 2011 – Jun 2011

Employer: R-Systems Inc.

Project Description

Wave III project consists 6 custom reports build on Argus Insight data mart. These reports help users to analyze the critical data before submitting to FDA.

Report Name

PSUR Cumulative Summary

Periodic QC Report

Periodic QC Labeling Assessment Overrides

Periodic Tabulation of case counts

Periodic Tabulation of event counts

Periodic Tabulation of all cumulative data (standard report)

Submissions to the FDA(Drug/Device) by License ID QC Report

Responsibility:

Client interaction to identify the user requirement

Developed technical design document for reports

Developed complex reports (cross tab)

Writing IQs for all reports

Argus Insight 7.0

Client Name: Oracle India

Organization: Oracle India

Environment: ASP 3.0, ASP.Net 2.0, Oracle 11g, Net Framework 3.5 Microsoft Visio 2007, Cognos 8.4

Team Size: 14

Role: Development Manager

Duration: Sep 2010 – Jan 2011

Project Description

The current focus and theme of the Oracle suite of Safety and Pharmacovigilance products is the enablement of the CRO. CROs are enjoying a significant growth as pharma companies move to conserve costs and gain operational efficiencies. As such, AI must be enhanced to serve the CRO market with a multi-tenant application.

Responsibility:

Involved in Client Interaction (Product management group and Product strategy group) for new roadmap of Product

Identifying the changes in reporting module due to multitenant architecture

Developed technical design document for reporting module

Integrated ASP/.Net application with Cognos using SDK

Code reviews

Argus Insight 6.0

Client Name: Oracle India

Organization: Oracle India

Environment: ASP 3.0, ASP.Net 2.0, Oracle 11g, Net Framework 3.5, Microsoft Project Plan 2007, Microsoft Visio 2007, Business Objects XI, Cognos 8.x

Team Size: 7

Role: Development Manager

Duration: Dec 2009 – Sep 2010

Project Description

Argus Insight, formerly called Power Reports is a highly optimized reporting module that compliments Argus Safety. The Argus Insight Extract Transfer and Load (ETL) engine extracts data from the Argus Safety database and populates a data warehouse in a format that allows efficient querying. The various query, drill down, and output components of Argus Insight let you analyze your safety, workflow, or product data from all angles and produce reports that provide immediate business impact and maximum efficiency in decision making.

Responsibility:

Involved in Client Interaction (Product management group) for new Product features

Managed Project Plan (Scheduling, Monitoring & Controlling, Communication) using Microsoft Project 2007

Involved with design team and participated in various design approaches

Handled virtual team

Code reviews

Interaction with Oracle performance team

Argus Safety (4.1, 4.1SP3, 4.2)

Client Name: Relsys International (Acquired by Oracle)

Organization: Relsys India Pvt Ltd.

Environment: ASP, VB 6.0, C++, Power Builder, Oracle, Net Framework 2.0

Team Size: 6

Role: Tech Lead / Project Lead

Duration: March 2005 – Apr 2006

Product Description

Provide visibility of strategic data across the enterprise and a focal point for all core business activities

Provide focus on key, statistically significant data that would be difficult to uncover without the proper automated tools, solving the need for data insights that manual processes alone cannot accomplish

Explore, compile and analyze known data, solving the need for product, event and productivity knowledge to enable key business decisions to be made

Manage regulatory compliance needs, improve case workflows, and enable the exchange of core data with other systems, thus solving compliance and data management needs

Responsibility:

Delivered Argus Safety 4.1 SP3 service pack

Handled Argus Safety Database

Created PL/SQL stored procedures

Testing / Implementation

Design team member of Console Conceptualization and developed POCs

Novo Nordisk Data Cleanup Project

Client Name: Novo Nordisk

Organization: Relsys India Pvt Ltd.

Environment: Oracle, PL/SQL

Team Size: 3

Role: Tech Lead / Project Lead

Duration: Oct 2005 – Nov 2005

Product Description

The configuration of product families, products, licenses and datasheets in the Novo Nordisk global safety Argus Safety database has been updated in the past to incorporate new business needs and newly defined standards which has created a need to realign the data in Argus Safety with this new configuration.

A first ‘cleanup’ project called phase I has been performed which has restructured configuration and case data for product families, products, datasheets and licenses.

A second ‘cleanup’ project called phase II, which is the subject of this project, is required in order to continue this restructuring according to specific requirements and in order to correct also a few shortcomings of phase I with regards to configuration and case data. The goal is to achieve a fully coherent Argus database and application with none of the functionalities (such as expedited reports scheduling and generation of follow-up reports) being hindered by any side-effects of the restructuring of the configuration data

Responsibility:

Developed PL/SQL scripts to clean up the business configurations (products, product families, datasheets, licenses)

Testing / Delivered

Easy Trak Web

Client Name: Relsys International (Acquired by Oracle)

Organization: Relsys India Pvt Ltd.

Environment: .Net Framework 1.1, ASP.Net, C#, ADO.Net

Team Size: 15

Role: Tech Lead

Duration: Feb’ 2004 – Jan ‘2005

Product Description

EasyTrak™ has set the standard for medical industry complaint handling systems. It not only helps manufacturers of medical devices, drugs and biologics respond to customer complaints, but also assists in the proactive development of corrective action plans. With a single keystroke, EasyTrak™ can provide data to help you analyze trends and identify the root cause of an event. It is this type of automation within EasyTrak™ that takes the worry out of regulatory compliance.

Responsibility:

Analysis and Requirement gathering using UML methodology

Developed CAPA module (Corrective action and Preventive action), Configuration, List Maintenance using ASP.Net 1.1

Used Infragistics (3rd party) control

Created PL/SQL stored procedures

Testing / Implementation

EDUCATION

Graduation: Bachelor’s in science (Math’s)

Certification(s)/ Others: 2 yr. Advanced Diploma in System Management from NIIT in 1997. Certificate in Oracle Developer 2000 from SQL* International in 1997.

Pursuing M.Sc. (IT) from Amity University

Certified PMP

Informatica 8.6 training from Aroha Technologies

Post Graduate Diploma in Clinical Research and Pharmacovigilance from ICRI

Machine Learning certificate from Coursera



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