Customer Service Project Management
Resume:
Rachele Pierre
Worcester, MA **606
Cell: 508-***-****
Email: *********@*******.***
PROFESSIONAL EXPERIENCE:
Fresenius Medical Care, Waltham, MA (4/2015 – 6/2017)
Senior Post Market Surveillance Specialist
Applied knowledge of drug/device regulatory requirements to support the Post Market Clinical Surveillance MDR/ADE reporting process and evaluated complaints for MDR reporting utilizing product knowledge and Decision Trees.
Participated and supported internal and external FDA audits.
Performed queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
Met Accuracy Goals (95% accuracy goal). Ensured data was collected through routine business processes and reviewed for accuracy, timeliness, relevance, completeness, understood by users, and quality
Responsible for receiving, reviewing, entering, and evaluating data into the Compliant Management Database regarding customer/patient product inquiries.
Interfaced with Customer Service and customers/patients to gather additional information required for complaint investigations, including the retrieval of product samples.
Provided coding support and reviews and updates complaints in the Compliant Management Database.
Partnered with sales, marketing, and manufacturing departments to resolve product problems and provided feedback to customers as needed.
Provided training during orientation and on-boarding of new staff.
Determined product and incident complaint codes and respond to questions regarding complaint coding from staff members.
Assisted with Supervisorial review in ensuring the timely coding of completed investigations, closure of all complaint files, and ensures that all pertaining information is contained consistently and uniformly within the file prior to closure.
Philips Healthcare, Andover MA (11/2010 – 4/2015)
Quality Specialist II/ Team Lead
Managed global recall programs.
Managed multiple Quality System projects that included managing system corrections, defects, and enhancements to ensure compliance with quality system requirements.
Participated in the development of Recall Programs and Procedures.
Evaluated audit findings and implement appropriate corrective actions.
Prepared reports to communicate outcomes of quality activities.
Investigated Corrective and Preventative Action (CAPA) deliverables and initiated clearance for owners to proceed to the next CAPA process step.
Provided training during orientation and on-boarding of new staff.
Liaison to Philips Healthcare (PH) from Imaging Systems (IS) level process in respective to Quality System elements.
Led global business initiative to unify key market field action communication- resulting in global process and template used across all Philips Healthcare.
Responsible for training multi-national business units with current field action process.
ICON plc, Marlborough, MA (05/2008 - 11/2010)
Clinical Data Manager Associate
Reviewed logic check outputs, Case Report Forms (CRFs), and listings to identify missing or discrepant data on Phase I Oncology trials.
Produced manual as well as automated Data Clarification Forms (DCFs) to review queries for accuracy on Phase III Oncology clinical trial.
Resolved data discrepancies and ensured completeness by reviewing source documents.
Assisted with the reconciliation of Clinical Adverse Events (AEs) with Serious Adverse Events (SAEs) per established guidelines.
Conducted various quality check audits on Phase I & II cardiovascular studies prior to database lock.
Tracked and administered all project related queries/data clarification forms as related to project database.
Assured compliance in Good Clinical Practices, FDA regulations necessary and company standard operating procedures.
Sunovion Pharmaceuticals Inc., Marlborough, MA (08/2007 - 05/2008)
Medical Information Coordinator
Directed the initial handling/triaging of all incoming calls and requests for medical information.
Maintained and archived completed medical information case files.
Coordinated team meetings and recorded meeting minutes.
Researched and responded to written and oral inquiries from internal and external customers.
Developed standard response documents, created unique responses, and revised/updated existing documents.
Liberty Mutual Insurance., Westborough, MA (04/2003 – 08/2007)
Senior 3rd Party Claims Adjuster
Interviewed claimants, medical specialists, and employers to determine pertinent claim information.
Identified, collected evidence, and determined its value to a specific claim. Conducted interviews, gathered detailed information, and completed field investigations.
Reviewed and analyzed suspicious and potentially fraudulent insurance claims.
Reduced loss ratios through fair and prompt processing of claims.
Mentored new members of the claim staff.
Documented all investigation activity and presented reports to management.
Obtained and maintained property and casualty licenses in all New England states
Education:
Walden University –Master’s in Healthcare Administration, GPA 3.75, 2013, Minneapolis, MN
Becker College – Bachelors of Science in Business Administration, 2007 Worcester, MA
Six Sigma Green Belt – Philips Healthcare/ASQ, 2012
Project Management Certification – Academy of Project Management, 2016
Regulatory Proficiencies
FDA 21 CFR: 803- Complaint Management- MDR/MDV
806- Recalls & Enforcement Policy
820.100 CAPA
ISO 13485- Quality System Regulation
ISO 14971- Risk Management
INFORAMTION SYSTEMS:
MS Office (Word, Excel, PowerPoint, Access, Outlook), Trackwise, SAP, SharePoint, Pilgrim
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