On-site Lead and Major Incident Manager Resume

OBJECTIVE

To get myself exposed with different methodologies and to work in a professionally managed organization; where I can utilize my capabilities for the achievement of goals and update myself. I will endeavor to be always ready for the challenges.

SUMMARY:

About 10+ years of experience in all activities of Clinical Research, Pharmacovigilance, going up to Submissions and approval.
Seasoned techno - functional professional for implementation, support and maintenance of Oracle Argus Safety
ORACLE trained professional for Oracle Argus Safety, Oracle Clinical (OC), and Life Sciences Data Hub (LSH).
Good knowledge of Pharmacovigilance, Safety reporting, Clinical Trial process, Data Management, Safety Data Processing and applicable regulatory requirements (21 CFR- Part 11, ICH-GCP, EMEA, DCGI etc.)
Experienced in writing and maintaining Safety system documents like SOPs, FRS, URS, Process Guidelines, Standard Templates etc.
Experienced in Client Management, Vendor Management, Project Management and Team Management.
Completed executive Education Program in Project & Operations Management (eEPOM) from Indian Institute of Management (IIM) - Kozhikode.

TECHNICAL SKILLS

Oracle- Argus Safety Suite
Oracle Clinical (OC) & Remote Data Capture (OC-RDC)
Oracle- Life Sciences Data Hub (LSH)
Oracle- Empirica Safety Signal (ESS) thinkCLINICAL- Electronic clinical data capture and management application
Toad for Oracle/ Pl-SQL Developer
CoDER (Corporate Directory and Environment Repository) (MedDRA and WHO Drug Coding System)
ECLIPSE (Electronic Clinical Image Processing System)
OBIEE (Oracle Business Intelligence Enterprise Edition)

PROFESSIONAL EXPERIENCE

On-site Lead and Major Incident Manager

Confidential

Responsibilities:

Oversee incident management for all end users for Oracle Argus Safety
Configuration of new E2B destinations, helping business in their testing.
Managing and coordinating with different teams during a major incident/ outage
Understanding the reported issue and resolving it accordingly
Testing of application after up gradation and patch implementations
MedDRA up-versioning activities
Reporting Gateway maintenance and ensuring that all its certificates are valid
Solution Architect for customizations as suggested by business
Mentoring and guiding the team on reported incidences
Preparation of Weekly status report (WSR) on the incidences and analyzing the recurring issues

Project Manager and Lead

Confidential

Responsibilities:

Collection of specifications for integration of Argus with TMS for MedDRA, MedDRA J, WHO Drug Dictionary and J Drug Dictionary
Developing the integration strategy and guiding the technical team on same
Performing the required documentation on Change Management, updating applications specific documents (like FSDS, CBD etc.)
Writing the Installation Qualification (IQ) scripts for installation
Work closely with the Quality Management Groups (QMG) to ensure compliance with specifications, SOPs and any other applicable local and International regulations
Performing the Operational Qualification (OQ) and Performance Qualification (PQ) of the integration
Guiding the technical team for customization at Argus for MedDRA re-pointing
Sharing the Weekly Status Report (WSR) for project with client and getting it approved
Guiding the finance team on reached milestones and their subsequent invoicing

Techno-functional Consultant

Confidential

Responsibilities:

Collection of URS and FRS for Oracle Argus Safety Suite
Implementation of Argus Safety suite application- Access management configuration, Business configuration and System configuration
Work closely with the Quality Management Groups (QMG) to ensure compliance with specifications, SOPs and any other applicable local and International regulations
Writing Functional test specification, test cases and execution of same
Performing the Installation Qualification (IQ) and Performance Qualification (PQ) of installed Oracle Argus Suite Applications
Guiding the technical team for customization of Argus
Development of test scripts and testing the application post customization and patch application