Project Manager Quality Assurance

Jacquelyn Chiarella

Flemington, NJ ( acczo9@r.postjobfree.com c: 908-***-****

Product Complaint Technician

Seeking Product Complaint role in Clinical Research for a Pharmaceutical or

Biotech Company

P

roduct Complaint Technician with strong knowledge of many therapeutic

agents and devices used for diagnosis and treatment of diseases. Highly

experienced professional with a demonstrated and robust record of

accomplishments in Pharmaceutical Product Complaints, Drug Safety, Data

Management and Data Coordination.

Select Qualifications & Achievements

. The College of New Jersey Graduate - Bachelor of Arts

. 1+ years of Product Complaint management

. 2+ years of Clinical Data Management

. 4+ years of EKG Data Management experience

. Experience with Endocrinology, Oncology, Transplantation Medicine,

Women's Health, Infectious Diseases and Cardiology

. Proficiency in communication and presenting MS PowerPoint slides in a

group setting

. Knowledgeable with EDC platforms

Professional Profile

Ethicon

A Johnson & Johnson Company (Contractor)

Complaint Analyst

November 2013-Present

. Manages product complaints using the electronic system CHATS

. Makes MDR/MDV decisions for product complaints.

. Provides timely process and response to external customer for closure of

product complaint.

. Differentiates between product inquiry and product complaint and forwards

to respective location for prompt customer service.

. Provides support to Ethicon facilities during audits.

. Accountable for all product complaints from inception to closure as well

as corrective action follow-up

Sanofi Pharmaceuticals (Contractor)

Product Complaint Technician

March 2012 - September 2013

. Accountable for the successful and timely completion of customer

complaints received for the products manufactured by Sanofi

. Review complaints to determine need for further investigation

. Responsible for the coordination, administration and resolution of

product complaints originating from customers

. Coordination with manufacturing sites in supporting product complaint

investigations in a timely manner

. Populating and synchronizing databases from call centers to manufacturing

sites

. Meticulous verification of data points for case closure

. Confirm and authenticate returned product for forwarding to investigation

sites

. Creation of product complaint cases based on unsolicited product returns

Pfizer, Inc. (Contractor)

Drug Safety Assistant

October 2010 - August 2011

. Distribution of requests for follow-up information for US-sourced

adverse event reports to consumers and healthcare professionals across

therapeutic teams

. Generation of follow-up letters for US-sourced adverse event reports

and tracking of distribution

. Review complaints to determine if follow up is required

. Distribution of requests for follow-up information for US-sourced

reports of adverse events not meeting reporting criteria

. Generation of follow-up letters for US-sourced reports of adverse

events not meeting reporting criteria

. Interact with therapeutic teams to customize standard letters as

necessary

. Review and quality assurance of follow-up request packages

. Assure accuracy of tracking of distribution of US follow-up letter

requests

. Contribute to assessment of the timeliness of US follow-up letter

request distributions against applicable guidelines and procedures

. Interact with therapeutic teams and management, as appropriate,

relative to quality issues as necessary

. Support therapeutic teams relative to processes for forwarding of

cases requiring follow-up letter distribution, source documents and

adverse event case files as needed in support of case processing

across DSS sites

. Archiving of adverse event source documents as needed, DSS Outbound

queries and Follow Up Letter correspondence

. Quality assurance of legacy case file order for DSS source documents

of individual case safety reports- Assure accuracy of tracking of

archiving of adverse event report

. Interface with DSS customers, including therapeutic teams and

functional areas regarding source documents and legacy case files

Beardsworth Consulting Group, Inc.

Clinical Data Coordinator

February 2008 - November 2009

Assume responsibility for the reviewing of case report forms:

. Participate in the development of case report forms, case report form

completion guidelines, edit checks, data entry guidelines, coding

guidelines, and data review guidelines to ensure compliance with

Beardsworth data management standards and the study protocol

. Ensure consistency in reviewing and coding within a project

. Document exceptions to guidelines once approved by the project team

Authorize corrections to the database:

. Generate standard edit checks and data review listings

. Collaborate with client/clinical operations to properly evaluate data

. Update database based on response received

Assume primary responsibility for the execution of assigned projects:

. Maintain project file, in accordance with client standard operating

procedures, to document all data management related study procedures

. Generate data resolution queries

. Convey progress of critical data management activities to project team

. Create and/or run standard programs to ensure data integrity

. Create Data Management Plans

. Communicate/coordinate with project manager, statistician, clinical

research associate, database manager to ensure clean database

. Participate in database lock

. Interact with clients as necessary

ERT, Inc.

Data Coordinator

September 2003 - April 2007

. Worked with Data Coordinators I, II, and III to ensure both company and

department SOPs and Working Practices were being followed

. Ensured protocol compliance according to Data Collection Plan

. Conducted training of all new members of the Data Coordination Department

. Directed the daily workflow of the department by assigning staff to

projects

. Generated, issued, and resolved numerous queries

. Participated in study start up and data base lock

. Entered data into system

. Worked in the therapeutic areas of oncology, cardiology, infectious

disease, immunology, and pediatrics

. Experienced with ERT's organic EDC platform

Contact this candidate