Customer Service Medical Device

Heather M. Veliz, M.B.A.

**** ***** **. *********, ** 93012

805-***-****; ******@******.***

SUMMARY OF QUALIFICATIONS

• Excellent communication skills with strong analytical, interpersonal, and research skills; strong customer service orientation.

• Perceptive in professional business concepts and company objectives to resolve complex issues in creative and effective ways

• Highly motivated and able to multitask, pay attention to detail and work effectively both independently with minimal

supervision and in team settings to meet all deadlines and companywide changes.

• Exercises judgment to take initiative, anticipate needs, and demonstrate a willingness to learn new approaches/skills.

• Knowledge of Good Clinical Practices (GCP’s), Good Manufacturing Practices (GMP’s), & CFR’s.

• Strong computer skills: Microsoft Office (Word, Excel, PowerPoint, Outlook), Clinical Trials Management Systems (IMPACT

and FileMaker Pro), Photoshop, SmartDAR, FirstDoc, Oracle Clinical (OC), Integrated Review (IR), CRF Track, SharePoint,

SPDR, IVRS, SAP, SPSS, TrackWise, DocuNECT and SalesForce.com.

EDUCATION

California Lutheran University, Thousand Oaks, CA (CLU)

February 2011

Master of Science in Business Administration (MBA) with emphasis in Management and Organization Behavior

California State University Channel Islands, Camarillo, CA (CSUCI)

May 2009

Bachelor of Science Degree in Business Administration

Bachelor of Arts Degree in Economics with Professional Track in Managerial Economics

PROFESSIONAL EXPERIENCE

Allergan

Clinical Product Surveillance Analyst April 2013 - Present

• Initiate and set up complaint files. Maintain and update database. Record all complaint activity in both hard copy (when

applicable) and computer files. Code complaint information according to Alternative Summary Reporting (ASR) and Product

Spreadsheet Report (PSR) to the FDA. Make Medical Device Reporting decisions within specified timelines.

• Responsible for completing and submitting MedWatch Supplemental Reports to the FDA associated with the use of a medical

device.

• Assess incoming documentation and medical information, for complaint data and ascertain compliance to product specification

and/or intended use as indicated in the product labeling. Evaluate internal and external lab analysis. Interface with product

return lab regarding analysis results and processing complaints.

• Initiate Further Investigation, and any additional follow-up and communication pertinent to the Medical Device Reporting as

needed. Track files sent to Q.A. for Further Investigation and complete necessary documentation. Evaluate Further

Investigation results, summarize findings, and determine and document the conclusion(s).

• Maintain a knowledge and understanding of current Medical Device Reporting regulations/ guidelines, product labeling, other

federal laws governing medical devices.

• Responsible for following up on root causes and corrective actions regarding the complaint.

• Prepare and present a Safety Presentation to entire Product Surveillance Department at Quarterly meetings.

• Establish and maintain relationships with both External and Internal Customers.

• Interfaces with call centers, various Allergan departments, sites, business partners.

Study Management Associate (SMA), Hyaluronic Acid Gel/Breast Implant Studies January 2012 – April 2013

• Compiles and distributes all site initiation study start up packages and supplies (CRF booklets, enrollment logs, study binders,

etc).

• Attend all team meetings and teleconferences to finalize and update the Protocol and Amendment Specification procedures.

• Participate in all relevant and required SOP and in-house training seminars.

• Support Study Start Up by testing subjects in IVRS for configuration specifications and study specific requirements; update the

Address Gateway and Impact as necessary.

• Assist in generation, compilation and distribution of essential regulatory documents (e.g. Clinical Disclosure Agreement,

Investigator Agreement, Clinical Trial Agreement) to sites and updating these essential documents in the Impact.

• Upload and track Site Protocol Deviation Issues in SPDR.

• Assists in ensuring adherence to applicable Allergan Medical SOPs, & ICH/GCP guidelines; help identify documentation non-

compliance to ensure updated regulator y documents (e.g. medical licenses, ECs, IRBs) are on file & current for each site

Heather M. Veliz, M.B.A.

7037 Quito Ct. Camarillo, CA 93012

805-***-****; ******@******.***

• Review Monitoring Visit Reports (MVRs) to make sure all information received was documented and applicable.

• Coordinate the collection and processing of clinical data received from investigational sites, including instruction to the sties on

their roles and responsibilities to the study to ensure complete and accurate clinical data.

• Assist investigational sites with 100% device accountability.

• Track Study Metrics (data queries, device reconciliation, issue resolution) for timeline accountability.

• Identify and help resolve issues that deviate from study protocol with the investigational site.

• Assist investigational sites to obtain, maintain, or close out their Institutional Review Board (IRB) coverage for the duration of

the clinical trial.

• Handle all incoming calls and field questions from various investigational staff, and solve a variety of customer service related

issues including many medical questions pertaining to the study.

• Help facilitate communication across departments and elevate site and study issues as appropriate.

• Ensure the accuracy and completeness of the investigational site Trail Master File prior to final archival.

Symbion Research International (CRO)

Clinical Operations Coordinator September 2010 - January 2012

• Assisted management in the development and implementation of clinical programs/studies with administrative activities that

supported clinical trials for medical devices; provided operational excellence through high level business support and on

call/day support for in house training programs and facilitation of new hire orientation;

• Revised SOPs and implemented CDM improvements to streamline the processes to maintain compliance with FDA

• Analyzed, assembled, researched and updated regulatory data for clients and special projects; organized databases; maintained

complex, integrated project timelines for development projects as well as received, verified, logged, and filed project

documents and assisted in providing documentation for inspections/audits

• Oversee the preparation and delivery of standard reports, safety reports, expense reports, monthly budget analyses,

presentations, spreadsheets and other project documents; prepare check requests and invoices.

• Tracked, managed and followed up with study related activities and projects including: Essential study documents, study site

correspondences, site monitoring visit reports, product shipments & reviewed documentation to determine if quality

requirements have been met; created and provided overall maintenance for clinical data entry & ensured employee files were

completed to meet licensing/compliance requirements.

• Exposure with Co-monitoring with CRO CRAs to ensure consistency and adherence with key study documents

such as the protocol and monitoring plan; Identify issues and work with the CPM/Monitor to suggest and

implement preventative actions globally.

• Organized/Prioritized workflow by maintaining individual and team calendars across multiple sites, coordinated local and

international travel and meetings, visitor accommodations, material delivery, and maintain orderly & electronic paper files.

Merrill Lynch, Westlake, CA

Global Wealth Management Advisory Intern November 2010 - February 2011

• Assisted with the coordination of portfolio creation and analysis to help design investment plan for clients.

• Developed client profiles on Sales Force, while exposed to client interaction and relationship building.

• Supported office initiatives and provided dedicated administrative and sales support to Financial or Private Advisors.

• Performed specific departmental recruiting needs including screening of candidates, contacting applicants, scheduling

interviews, leading interviews with new interns, and data entry of documents within internal HR database.

Chuy’s Mesquite Broiler, Camarillo, CA

Restaurant Manager May 2005 - November 2010

• Promoted from Restaurant Associate to Restaurant Manager

• Managed staff, provide training in customer service skills, money transactions & conflict resolution, hire, layoff, schedule

employees, and lead by example in promoting teamwork.

• Reconciled cash & credit transactions to maintain restaurant yearly, quarterly & monthly benefits and budget, prepare deposits,

submit invoices, check requests & reimbursements; assist in the coordination of company fundraisers, charity events, catering

engagements & distribute flyers.

• Coordinated as well as completed a training program on affirmative action, hiring procedures, union regulations, EEOC

compliances, safety and security procedures and labor laws.

• Managed operations including inventory control, purchasing and quality insurance. Maximized revenues through efficient

staffing, labor cost controls and promotions.

SEMINARS/WORKSHOPS

Heather M. Veliz, M.B.A.

7037 Quito Ct. Camarillo, CA 93012

805-***-****; ******@******.***

• Communicating in Color Class

• The Seven Habits of Highly Effective People (2-day course)

• Site Management Training: The Allergan Medical Monitoring Model (~50 Hours)

• Harvard Manage Mentor classes: Stress Management, Difficult Interactions, Goal Setting, Time Management, and

Writing Skills.

• Adverse Event Reporting & Protocol Deviations in Medical Device Clinical Studies (2-day course)

• Excel Functions + Formatting; Excel List, Databases and Tables; Excel Advanced Features; Excel Tips and Tricks;

Excel Macros; Microsoft Excel Pivot Tables

Contact this candidate