Management Medical

KARPAGAVALLI SIVAKUMARAN

Goleta, California ***** H 805-***-**** C 805-***-****

*******@*******.***

SUMMARY

A detail-oriented and analytical operations analyst with a

demonstrated track record of achievement in compliance, application

development, ISO 9001/CMM level 5 standards, federal regulations, and

data extraction/analysis. Established capabilities in ad hoc

reporting, training, presentations, internal audits, investigations,

and troubleshooting. Utilizes a sense of logic with a practical

demeanor to determine the actions needed to go forward and sets clear

expectations while fostering an environment focused on achieving

sustainable results. Incorporates new concepts and changes through a

broad-minded and adaptable mindset.

ISO 14155

Code of Federal Regulations (21 CFR)

International/Medical Device Regulations/Guidelines

ICH, GCP, ISO 14155, FDA 21, CFR 812 Regulations

TECHNICAL SKILLS

Microsoft Office Suite, Clinical Trials Management Systems like IMPACT

and FileMaker Pro, TrackWise Complaint Management System, Oracle

Clinical, SAP, Business Objects, InfoView, Smart DAR, SharePoint,

FirstDoc, Ad Hoc Query Reports, CRFTrack, IBM Mainframe, DB2, CICS,

COBOL, JCL, C++, Programming with Visual Basic.net, Web Programming,

SAS programming.

EXPERIENCE

ALLERGAN MEDICAL Goleta, California

Risk Management Analyst 2014-Present

. Conducted data extraction and analysis of data from complaint database

and prepared reports and graphs for delivery to regulatory bodies,

executive management, and departments.

. Handled data of confidential nature, including complaint information

and sales figures.

. Assisted in preparation of management presentations and provided

information for internal and directive from management to external

sources. Ensured quality and accuracy of data and ability to prepare

data in different formats based on need.

. Implemented reports and data for regularly scheduled monthly

operations quality reviews across different sites, including Marlow,

Costa Rica, and Santa Barbara, and provided data for regularly

scheduled updates for marketing, product surveillance, and finance,

with ability to add scheduled reports for other departments.

. Facilitated ad hoc reports and handled submission of eASR, PSR,

baseline reports, and other MDR data as needed to FDA per 21 CFR part

803.

. Analyzed information obtained by product surveillance personnel and

verified decisions for reportability under MDR regulation, 21 CFR 803,

ISO 9001, ISO 13485:2003, and Canadian regulations.

Senior Analyst 2013-2014

. Investigated and maintained complaint files, following complaint

handling regulation 21 CFR 820.198 and internal procedures. Analyzed

information obtained and facilitated decisions for reportability under

MDR regulation, 21 CFR 803, and international regulations.

. Evaluated internal/external lab analysis and interfaced with product

return lab regarding analysis results and processing complaints.

Maintained knowledge of current MDR

regulations/guidelines/interpretations, product labeling, other

federal laws governing medical devices, Department of Transportation

requirements for explant returns, and FDA-mandated Retrieval Program.

. Generated and submitted MedWatch forms to FDA and Vigilance forms to

international competent authorities.

. Trained new staff and conducted training/re-training on company

policies, study protocols, MDR regulations, and departmental

practices.

. Developed accountability system for tracking customer complaints and

to ensure FDA compliance. System resulted in 100% completions for a

consistent 12-month period.

ADECCO GROUP U.S.A.(Client: Allergan Medical ) Goleta, California

Study Management Associate, Clinical Research 2011-2013

. Worked on Allergan Medical (formerly McGhan Medical Corporation) Style

410 Silicone-filled Breast Implant Clinical Study 410 CA and CARE

study.

. Performed work on Allergan Medical (formerly McGhan Medical

Corporation) Silicone-filled Breast Implant Adjunct Clinical Study.

. Functioned as Adjunct study investigational site closeout

coordinator/trainer, Adjunct study corrections coordinator/trainer,

and Adjunct study device accountability coordinator/trainer.

. Conducted internal audits of Trail Master File and coordinated

collection/processing of clinical data received from investigational

sites, including instruction to sites on study roles/responsibilities,

to ensure complete and accurate clinical data. Identified and

resolved issues deviating from study protocol with investigational

site while assisting investigational sites to obtain, maintain, or

close out Institutional Review Board coverage for duration of clinical

trial.

. Reported study metrics to management, including data queries, device

accountability, issue resolution, and site closeouts while tracking

personal/team progress on Excel spreadsheets.

. Issued payments to patients and sites and assisted investigational

sites with 100% device accountability while writing/revising

department procedures as assigned.

. Provided assistance to sites with patient compliance and transferring

of patients to another investigational site. Devised required

materials for scheduled site monitoring visits.

. Provided leadership to the study management team in engaging

delinquent sites to bring their offices under compliance per study

protocol. Conducted analysis and developed plan that would achieve

the desired outcome. Within 12 months, 100% compliance obtained.

ADDITIONAL EXPERIENCE

COMPLETE BUSINESS SOLUTIONS INDIA, LIMITED, Tamil Nadu, India, Application

Developer, 1998-2001. Conducted project with State Teachers Retirement

System of Ohio and United Defense Limited Partnership. Prepared design

specifications and created/modified modules as per specification.

Conducted periodic quality assurance review and unit/system testing for

quarterly releases and modified modules per specification. Maintained and

supported various releases contributed by offshore team.

EDUCATION

BHARATHIYAR UNIVERSITY, Coimbatore, Tamil Nadu, India, B.E., Electronics,

Communication

PROFESSIONAL DEVELOPMENT

Allergan Medical, Site Management Training

CITI-Collaborative Institutional Training Initiative Online, Human Subjects

Research

CITI-Collaborative Institutional Training Initiative Online, Good Clinical

Practice

Harvard Manage Mentor, Process Improvement

Harvard Manage Mentor, Time Management

Harvard Manage Mentor, Writing Skills

Harvard Manage Mentor, Goal Setting

Harvard Manage Mentor, Presentation Skills

Mt. San Antonio College, Programming with C++, Programming with Visual

Basic.net, Web Programming

SAS Programming(Certification in progress)

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