Blake Cifaldi

•Coordinate the initiation and completion of technical assessments for the Infusion therapy.
- Assist medical safety, design, software and manufacturing SME's in completing technical assessment.
•Review signal escalations to confirm coding and inclusion/exclusion
•Customer quality contact for risk assessments.
- Submit PE searches through Business objects
- Review coding and assist with determining inclusion/exclusion
- Create product event inclusion criteria's (PEIC) to allow D2D team to identify issues that have investigated
- Provide trainings for the D2D team to assist in identifying issues that have been investigated.
•Coding SME for the infusion team
•Led annual PEIC review for Neuromod therapies

• Responsibilities may include the following and other duties may be assigned.
• Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
• Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

•Perform the documentation of internal product event files in accordance with regulatory standards.
•Communicate with medical professionals, patients and sales representative to gather information.
•Experience with SAP database, Microsoft Office, computer systems (GCH, DART, MRCS).
•Also participated in extensive Medtronic product, drug delivery therapy/ITB training.

• Provided prompt, knowledgeable and courteous telephone assistance to customers seeking information about specialized medical devices and related prescription medications and products.
• Fine-tuned a solid sales technique essential for the merchandizing of over 30 medical products to a large and diverse customer base.
• Interpreted complicated insurance procedures for customers, articulating the specific circumstances resulting from the individual’s health insurance policy.
• Balanced multiple activities such as communicating with doctor’s offices, processing orders, and completing and filing paperwork.

• Cold called 20 or more prospective clients a day.
• Met with clients and explained the benefits of our product as well as the proper use of our product.
• Followed up with past customers to renew contracts and close deals.
• Helped manage marketing materials such as radio ads, newspaper ads, and open houses.