Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 • (xxx-xxx-xxxx • abc@xyz.com

 

Solutions-focused RN and Drug Safety Associate eager to offer 25+ years of combined, cross-functional experience with high-volume drug safety assessments, evaluations, reports, and processes, as well as proven nursing, leadership, and mentoring roles, toward supporting an ethical and progressive employer in optimizing success.

 

Profile of Qualifications

 

         Top-performer who demonstrates solid knowledge of drug safety reporting, as well as a broad scope of healthcare and nursing support skills; background in assessment of litigation cases; and processing of legal / non-legal reports for adverse events.

         Integral leader who contributes expertise with wide range of SOPs, and up-to-date federal regulations and applicable guidelines.

         Excellent communicator who seamlessly interfaces between FDA, EU, and additional regulatory agencies to meet goals, along with effectively networking between healthcare providers, nursing staff, administrative support personnel, patients, and families.

         Ambitious self-starter who offers superior attention-to-detail and sharp analytical abilities within deadline-driven situations.

         Recognized for job performance excellence with membership in United Who s Who and Cambridge Who s Who.

 

Education, Licensure & Certifications

 

Bachelor of Science in Nursing (Summa Cum Laude; Sigma Theta Tau)                                                                     Regis University

Associate of Applied Science in Nursing                                                                 Montgomery County Community College

 

Registered Nurse                                                                                                                                                    State of Pennsylvania

 

Inpatient Obstetric Nurse • BLS for Healthcare Providers • Neonatal Resuscitation • Third Trimester Ultrasounds

 

Professional Synopsis

 

Drug Safety Associate

 

         Apply sharp analytical abilities toward assessing, evaluating, and processing adverse event reports for litigation using NWAES, DEOIS, and coding dictionary databases per company SOPs, and prioritizing efforts as dictated by FDA and EU timeframes.

         Optimize administrative efficiency by registering incoming documents from DEOIS into a NWAES database, as well as processing serious / non-serious line listings for study therapies, and voids, consolidations, and corrections, as necessary.

         Ensure seamless business processes by maintaining accurate back files of reports per company guidelines.

 

Safety Surveillance Contractor

 

         Expertly analyzed, evaluated, and processed initial and follow-up drug reports of adverse events for MedWatch and / or CIOMS using ARISg and ARGUS databases to include prioritizing within federal regulatory and company SOP timeframes.

         Contributed strong research skills toward effectively coding events and drugs using MedDRA and WHO Drug dictionaries.

         Played a vital role in supporting operations by attending weekly team meetings for familiarization with new processing updates.

 

Safety Associate Contractor

 

         Demonstrated solid organizational talents toward compiling initial and follow-up reports of serious / non-serious adverse events and submitting data to sponsor within federal regulatory, corporate, and sponsor SOP timeframes.

         Processed reports using SCEPTRE and corporate databases, and reconciled SAEs and clinical databases with appropriate staff.

 

Staff Nurse Labor / Delivery / Nursery / Medical-Surgical / Oncology

 

         Utilized broad nursing knowledge to assess, triage, and care for patients during all stages of labor and delivery within a 1,300-delivery per year hospital to include providing immediate newborn care and resuscitation, and support within a Level II nursery.

         Planned and prioritized unit staffing to maximize use of resources and meet key objectives, along with serving as preceptor / mentor to new nurses and participating in hospital-wide standards and unit committees to improve protocols and procedures.

         Collected blood and other specimens from newborns and adults for lab studies; performed prenatal tests and procedures (i.e. non-stress tests, ultrasounds); counseled patients during labor and postpartum stages; and educated mothers in newborn care.

         Scrubbed and circulated in OR for cesarean births and recovered OR patients post-delivery.

 

Additional Job History

 

Medical Record Reviewer, Nursefinders, Plainsboro, NJ                                                                                                             2002

Charge Nurse (11 C 7), Dock Terrace Nursing Home, Lansdale, PA                                                                            1995 C 1997