Experience

Linical Americas

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Medical Information Associate

  • Oct 2014 - Present

  • Handles telephone calls for the Pharmacovigilance department, (Medical Affairs) and takes messages or routes calls as needed.• Follows up on issues as directed by the Project Manager. • Documents all actions in detailed, clear and objective telephone reports and/or memos.• Follows department SOPs to assist in handling calls regarding medical affairs questions, report intakes and technical questions.• Prepares and files relevant case information.• Assists with maintaining Medical Information files and documentation.• Prepares letters and memos in response to Medical Affairs matters.• Assists with management of the Medical Affairs database.• Performs other duties and projects as assigned.• Perform monthly literature search and reviews for client’s pharmaceutical products.• Processing of adverse events for marketed products, including: triage and the assessment of reports for serious criteria according to applicable SOP, ICH, and Federal Regulations; performance of data entry, narrative writing, and quality control by way of case reviews and sign-off; preparation of case reports for medical and regulatory review; ensures that all documents are sent for review within reporting timelines; assessment of case reports for due diligence; drafting information requests and quality control reviews; monitoring the status of post-marketing cases.• Assist with the preparation of both quarterly and annual PADER (periodic safety reports) for submission to the FDA.• Mentor and provide guidance to junior team members.• Support for Pharmacovigilance audits by the FDA.• Assists with product recalls.



Ranstadt (contractor)-UMAS School of Medicine

• Nurse Reviewer- PAU

  • Jun 2014 - Oct 2014

  • Coordinated the review process for services requiring prior authorization for MassHealth Durable Medical Equipment. • Excellent understanding of the Provider Manuel and MassHealth Regulationsand Federal Regulations; performance of data entry, narrative writing, and quality control by way of case reviews and sign-off; preparation of case reports. • Coordinated the review process for services requiring prior authorization for MassHealth Durable Medical Equipment. • Excellent understanding of the Provider Manuel and MassHealth Regulationsand Federal Regulations; performance of data entry, narrative writing, and quality control by way of case reviews and sign-off; preparation of case reports.



Tufts Health Plan

• United States
• Insurance
• 700 & Above Employee

• Pre-CertNurse Medicared Preferred

  • Nov 2012 - Jun 2014

  November 2012-June 2014 TMP-Pre-cert Department/Clinical Services Responsibilities: Nurse Reviewer-Medicare Preferred HMO Coordinated the review process for services requiring prior authorization by Tufts Medicare Preferred, including matching the coverage requests to the Medical Necessity Guidelines, documentation of the coverage determinations, and organizational determinations in CCMS and notification to the requesting provider within the established time frames. Expertise in Medicare /Medicaid Regulations and navigation of the CMS website and uses the NCD’s and LCD’s proficiently..



The Neighborhood Connection

• Clinical Instructor

  • Sep 2005 - Apr 2012

  Developed the CNA program at the Neighborhood Connections for Continuing EducationProgram Instructor for all course work. Developed the CNA program at the Neighborhood Connections for Continuing EducationProgram Instructor for all course work.



Lutheran Medical Group

• Medical Practices
• 100 - 200 Employee

• Staff Nurse

  • Aug 1998 - Apr 2012

  Staff Nurse at Lutheran Medical Group (Brooklyn Medical Associates)Fort Wayne, INAugust 1998 - April 2012 (13 years 9 months)Office Manager, Triage Nurse, Phone Nurse, Treatment Nurse, Scheduling, Utilization Review, for busy Family Practice Office Staff Nurse at Lutheran Medical Group (Brooklyn Medical Associates)Fort Wayne, INAugust 1998 - April 2012 (13 years 9 months)Office Manager, Triage Nurse, Phone Nurse, Treatment Nurse, Scheduling, Utilization Review, for busy Family Practice Office



Brooklyn Medical Associates

• Clinical Research Coordinator

  • 2006 - 2010

  Clinical Research Coordinator- A Trial of GI Safety of Celecoxib Compared With Non-Selective Non-steroidal Anti-inflammatory Drugs (NSAIDS) (GI-REASONS)Fort Wayne, INPrinciple Investigator-Dr. Robert H. Musselman2006-2010Prepared study material, organized study files, regulatory binders, study specific source documentation and other materials, screened all subjects for eligibility, assisted the Principal Investigator with scientific and compliance reporting requirements, collected data as required.



Community Home Health Care

• Home Health Care Nurese/UR Nurse

  • Apr 1993 - Jul 1998

  I worked as Home Care Nurse doing skilled nursing visits. I checked VS on all patients, listened to heart and lungs, and bowl sounds and did a complete physical assessment at each home visit. I communicated patients needs and concerns to their physicians. Education on their disease process and their progress was done at each visit. I would advocate for more time and care with their Dr. if necessary. I worked with the RN Case Manager on the Plan of Care and worked with the Home Health Aides for patient care when needed. I also completed utilization review on all charts at this agency and set up a continuing education programs for their Home Health Aides as they needed to complete an hour each month.



Lutheran Hospital

• Staff Nurse/Telemetry/Med Surgical Unit/Orthopaedics/Float

  • May 1985 - Aug 1990

  Staff Nurse/Telemetry/Med Surgical Unit/Orthopedics/Float at Lutheran HospitalFort Wayne, INMay 1985 - August 1990 (5 years 4 months)Staff Nurse on a Telemetry, Orthopedics, Med-Surgical, Psyche Unitsfloat to NICU, ICU Staff Nurse/Telemetry/Med Surgical Unit/Orthopedics/Float at Lutheran HospitalFort Wayne, INMay 1985 - August 1990 (5 years 4 months)Staff Nurse on a Telemetry, Orthopedics, Med-Surgical, Psyche Unitsfloat to NICU, ICU