Senior Consultant Resume

SUMMARY

Offering 10+ years of successful experience; Implementing and managing multiple R&D systems - Drug Safety/Pharmacovigilance (PV) and Regulatory.
Provide a unique blend of business acumen, technical expertise, and administrative background.
Strong background in delivering business solutions for pharmaceutical industries and regulatory agencies.
Extensive working experience with the FDA, EMA, and PMDA.
With technical acumen, business knowledge, strong leadership, and communication skill to leverage new technologies.

PROFESSIONAL EXPERIENCE

Senior Consultant

Confidential

Responsibilities:

Data Migration from legacy safety system to Global Safety System ARGUS
Worked on ARGUS, ARGUS JAPAN implementation project workshops for top Pharmaceutical MNCs.
E2B Data Migration, E2B+ Customizations for top-notch Pharma clients
Proficient in ARGUS Global as well as Argus J Custom Reporting
Design and development of custom reports using OBIEE BI Publisher and BI Answers
Experience in HP Quality Centre, JIRA
Life Sciences Regulatory Compliance including FDA - 21 CFR Part 11
Formulating strategy and approach for migrating cases that exist in up to 4 different databases used by company at different geographical locations
Conducted mapping to develop and confirm requirements
Writing complex SQL Minus Queries as a mechanism to Unit Test the migrated Data.
Designing Templates to accomplish the format required for complex reports like PBRER using OBIEE
Argus Safety, Argus Insight & Argus DLP understanding
Involved in Testing (Unit Testing) & Peer code review

Associate Consultant

Confidential

Responsibilities:

Changes-only support using Oracle’s Total recall.
Involved in the design/development of a robust tool called PUB ADMIN using plsql code.
Used the latest Oracle technologies like Flashback and Interval partitioning.
Design partitioning strategy and mapping database objects to physical storage devices
Fair knowledge of the ELT tool of Oracle.i.e. Oracle Data Integrator and the knowledge Modules.
Monitored and optimized the performance of Queries and databases.
Building knowledge and understand Apex application Development
In-depth knowledge of Sqlplus commands

Software Engineer

Confidential

Responsibilities:

Understanding the Requirement Specifications.
Designing Parallel jobs using DataStage Designer.
Extract, cleanse, transform and load data into the data mart using DataStage Designer.
Working on different stages like join, Merge, Lookup, Aggregator, Filter, Funnel, Copy, Sort stages etc.
Used Tivoli for Scheduling and to automate the whole process of data loading the Jobs based on the dependency.
Involved in Testing for preparing Unit Test cases and Test data.
Monitored /reviewed other ETL programmer’s deliverables on a team share basis to ensure that adherence to uniform application development practices are being followed.
To follow some techniques to improve performance tuning.
Unix shell scripting on IBM AIX 7.1 Operating system