Customer Service Medical
Resume:
NORMA A. RODRIGUEZ
Lake Bluff, IL 60044
ab8zka@r.postjobfree.com
November 2011 to June 2012
REGULATORY DATA ANAYLST
Experis/Manpower (Fresenius Kabi Pharmaceuticals), Schaumburg, IL (contractor)
• Data Input for Regulatory Profiles
• Process, Monitoring and analysis of Profiles NDA and ANDA
• Documentation Verification
• Profile sharing and importing
October 2008 to September 2010
PV COORDINATOR (May 2009 to September 2010)
Delta Pharma (Takeda), Lake Forest, IL (contractor)
• Daily processing of world-wide case reports into ARIS-g safety database
• Ensure accurate and timely processing of case reports within the department
• Perform MedDRA coding for adverse events, medical history, disease and risk factors
• Write narrative summary which includes subject information, circumstances surrounding the
reported event and relevant medical/non-medical information pertaining to the understanding of
the event
• Responsible for timely and accurate reporting to the regulatory authorities in accordance with
federal regulations
• Provide suggestions on work instructions for various studies/compounds
• Contribute to improving departmental processes
• Knowledge of regulatory requirements
• Completed SYR-322 legacy project which required learning the 322 study and entering approx.
250 initial cases within a three month timeframe
SOP PROJECT COORDINATOR (December 2008 to May 2009)
• Perform a variety of tasks for multiple managers and their staff
• Actively participate in projects and complete assigned tasks within established timelines
• Exercise basic reasoning skills and judgment in making decisions
• Make telephone calls, take accurate notes regarding responses and update tracking spreadsheet
• Produce simple documents and presentations with manager’s direction to effectively
communicate information
• Assist in organizing materials for the documentation process
PV COORDINATOR (October 2008 to December 2008)
• Daily processing of world-wide case reports into ARIS-g safety database
• Ensure accurate and timely processing of case reports within the department
• Perform MedDRA coding for adverse events, medical history, disease and risk factors
• Write narrative summary which includes subject information, circumstances surrounding the
reported event and relevant medical/non-medical information pertaining to the understanding of
the event
• Responsible for timely and accurate reporting to the regulatory authorities in accordance with
federal regulations
• Provide suggestions on work instructions for various studies/compounds
• Contribute to improving departmental processes
• Knowledge of regulatory requirements
• Completed SYR-322 legacy project which required learning the 322 study and entering approx.
250 initial cases within a three month timeframe
November 2006 to April 2008
PRODUCT SURVEILLANCE QUALITY ASSOCIATE I
Baxter Kelly Services, Round Lake, IL
• Process low-risk complaints
• Collect necessary complaint information
• Determine reportability of a complaint and submit associated Med Watch reports within 30 days
per regulations
• Evaluate complaints in order to investigate and coordinate sample retrieval
• Ensure complaint handling tasks are completed as required by company policies and procedures
• Ensure compliance with applicable industry regulations (e.g. FDA 21 CFR Part 820.198, FDA 21
CFR Part 803, ISO 13485-2003, etc.)
August 2003 to November 2006
DATA ENTRY TECH, PPD R&D
Abbott Laboratories, Abbott Park, IL
• Accurately and timely entry of high volume adverse event data
• Make appropriate modifications, insertions or deletions as directed by Safety Analysts
• Complete cases and assigned projects effectively and within required time frame
• Effectively prioritize workload
• Manage time to complete assigned projects
• Assign cases to individuals on a daily basis
• Update logs for cases in Excel
July 2002 to November 2003
CUSTOMER SERVICE SPECIALIST
Parker Hannifin Corporation, Lincolnshire, Illinois
• Customer service
• Order entry
• Processing price quotes
• Setting up new accounts
• Customer information requests by fax or mail
• Order follow up and tracking, expedite orders, returns, credits and collections
September 2000 to October 2001
CUSTOMER SERVICE REPRESENTATIVE
USA Bluebook Inc. Waukegan, Illinois
• Customer service
• Order entry
• Processing quotes
• Customer development
• Set up new customer accounts
• Customer information requests by fax or mail, enter fax & mail orders, order follow up and
tracking
Special Skills:
• Bilingual (speak, read and write Spanish)
• Microsoft Office (Word, Excel, Power Point, Publisher, Photo Editor)
• Lotus Notes Office Suite
• Adobe Acrobat 7.0 Professional, Windows 98SE, ME, 2000, XP
• Accurate and proficient with numbers, Accounts Payable/Receivable
Siebel, JD Edwards,SAP,SPP,TrackWise and ARISg5
Education: Waukegan West High School graduate
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