Registered Nurse Medical
Resume:
Nancy Rivkin
*******@*******.***
SUMMARY
. Registered Nurse with Drug Safety experience within the pharmaceutical
industry
. Strengths include assessing Serious and Non-Serious Adverse Events
. Excellent knowledge of Medical Terminology
SKILLS
. Proficient in Microsoft Office
. Excellent communication and interpersonal skills
. Detailed oriented with demonstrated success in managing diverse
priorities to
meet deadlines, highly organized
. Strong analytical skills used in effective decision-making
EDUCATION
1992
BSN University of Delaware
Nursing
PROFESSIONAL EXPERIENCE
April 2012 - Present ICON Clinical Research
Drug Safety Associate (Contractor)
. Processing and data entry of Oncology study reports (adverse events
and patient information) into ARISg database
. Writing safety narratives and coding events utilizing MedDRA coding
. Responsible for creating queries to send to study sites
. Responsible for maintaining case workload and adhering to Sponsor /
FDA timelines
. Prepare queries for individual study sites
April 2010 - December 2011 Johnson & Johnson
Drug Safety Associate (Contractor)
. Assume primary responsibility to collect details of adverse events
received by phone or mail and perform initial assessment according to
local procedures and in accordance with company global drug safety
procedures
. Create initial reports by directly entering information in Drug Safety
databases, amend reports and enter follow-up information as acquired,
and prepare report for FDA submission
July 2009 -February 2010 Aetna
Clinical Appeals Nurse Analyst
. Processing and making recommendations for provider appeals by
analyzing medical records, and referring to a medical director for
final review
. Process facility and/or physician appeals (hospital stay, medical
equipment, surgical procedures, pharmaceuticals) by selecting correct
ICD-9 procedure/diagnosis codes
. Conduct a review of medical documentation and utilize medical
knowledge, to provide a clinical determination
. Write a narrative summarizing the issue of the appeal, clinical
information provided, and personal recommendation
. Trained on several databases including patient management systems and
complaint & appeals systems
. Utilize time management skills to manage case workload and ensure
appeals are processed in a timely manner, in order to comply with
federal regulations
October 2008 - July 2009 Merck & Co., Inc
Adverse Experience Reporting Associate (Contractor)
. Identified, abstracted, and assessed Serious and Non-Serious Adverse
Events obtained from literature, phone calls, medical records and
investigator sites for marketed and study drugs
. Coded Adverse Events, wrote narratives, and submitted final reports to
the FDA in a timely manner.
. Proofed foreign Adverse Event reports (from foreign Merck sites),
determined the accuracy of the reports, and requested corrections to
the reports
. Requested clarification of study reports and related Adverse Events
from investigator sites
. Participated in the Unblinding process in studies where drug related
or possibly drug related Serious Adverse Events occurred and were not
an expected outcome
. Trained and utilized safety databases, New Worldwide Adverse
Experience System (NWAES) and DEIOS
July 2008 - October 2008 Omnicare Clinical Research
Drug Safety Associate (Contractor)
. Identified, abstracted, and reported Serious and Non-Serious Adverse
Events from legal documents and medical records for post-marketing
study involving litigation.
. Product was the marketed cardiovascular drug, Digitek, which had been
recalled
. Safety review of patient's clinical data
. Contacted patients regarding their adverse reactions to the recalled
drug
. Documented and processed Serious and Non-Serious Adverse Events,
spontaneously reported adverse events and other medically related
information per procedure
. Coded Adverse Events using MedDRA coding
. Responsible for writing Medwatches, and following Sponsor / FDA
timelines
June 2007 - April 2008 Icon Clinical Research
Drug Safety Associate (Contractor)
. Identified, abstracted and reported Serious and Non-Serious Adverse
Events from legal documents and medical records for post-marketing
study involving the Vioxx litigation
. Utilized MedDRA coding to code adverse events, and differentiated
between Serious and Non-Serious Adverse Events
. Data entered Adverse Events into NWAES and DEIOS database systems
. Provided input and reviewed relevant safety tracking systems for
accuracy and quality
. Responsible for writing safety narratives documenting the patient's
history and Adverse Event(s)
. Responsible for maintaining case workload and adhering to Sponsor /
FDA timelines
Major Accomplishments:
. Asked to be a back up reviewer
1997 - June 2007 St Christopher's Hospital for Children
ONCOLOGY TRANSPLANT UNIT
Responsible for complete nursing care in a seven-bed unit specializing in
the treatment of children with cancer. Administered chemotherapy, and also
provided medical care to neutropenic children. Partnered with several
hospital departments including respiratory, physical therapy, and other
physicians to ensure world class care.
Major Accomplishments:
. Successfully completed two week training at St Jude's Hospital for
Children in Memphis Tennessee
. Aided in preventing mistakes on written orders by meticulously
performing chart checks
. Nominated for star employee of the month
1992 - 1997 St Christopher's Hospital for Children
MEDICAL SURGICAL FLOOR
Responsible for 4 to 5 patients in a fast paced 30-bed hospital
environment.
Major Accomplishments:
. Reviewed several patient care assessments, recommending changes in care
based on own analysis.
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