
sharon mckeown
About
Contract position-Senior Scientist Dictionary Coding & Analytics-Drug Safety & Pharmacovigilance at JNJ
united states
philadelphia
pharmaceuticals
pharmacovigilance, drug safety, clinical trials, pharmaceutical industry, healthcare, ich gcp, clinical research, medicine, sop, oncology, cro, clinical development, regulatory requirements, biotechnology, gcp, drug development, american heart cpr for hcps, school nursing, community health and education, community health and wellness rn, standard operating procedure, regulatory affairs, good clinical practice
Experience

twin spring farm - school registered nurse
twin spring farm
Perform school nursing care from infant ages up to 2nd grade including performing 1st aide, triaging and prioritizing of multiple students situations and care; administer acute care to emergencies as needed; assessments of acute or chronic health situations/illnesses in pediatric population providing clear parent communications and school administrators as needed. Perform health screenings of illnesses.

employee health and occupational health registered nurse
abington memorial hospital
* Perform post offer employment physicals * Assess and perform return to work for Abington-Jefferson employees * Perform & initiate initial worker's compensation-provide follow-up as needed * Perform vision screenings * BAT and Urine drug screen testing performed.

contractual community health and wellness nurse
abington jefferson memorial hospital
* Work on a contract basis as a health and wellness nurse within the community. Nurse educator for elderly and clients of various ages regarding chronic disease * perform due diligence wellness calls post screenings * attend and manage health and wellness fairs and numerous health screenings to adult and senior populations. I also perform various health and wellness screenings.

substitute school nurse, registered nurse
colonial school district/centennial school district
* Perform school nursing duties within a large school district that includes elementary, middle and high schools. Provide education on health issues and disease management (asthma, diabetes) * perform 1st aide, triaging and prioritizing of multiple students situations and care * administer acute care to emergencies as needed * assessments of acute or chronic health situations/illnesses in pediatric population providing clear parent communications and school administrators as needed. Perform health screenings of illnesses.

johnson and johnson

charge and staff rn-- cardio-thoracic surgery and interventional and cardiology medical management
hahnemann university hospital
* Care of patients pre and post pulmonary and cardio-thoracic surgeries * Managed high acuity patients, bed control and preceptorship * Care and recovery of patients post catherization, coronary stents, pacemakers, defibrillators, and angioplasties, involving expertise in arterial catheters * Proficient electrocardiogram readings * Intravenous anti-arrhythmic and angina management/titration * Participated in academic clinical drug trials.

licensed healthcare registered nurse communicator-medical information
ashfield, part of udg healthcare plc
* Thorough delivery of drug/medical device product information * Provide drug/medical device product information * Completely and accurately document Adverse Events and Product Quality Complaints as per client and federal guidelines * Identify adverse events and product complaints with reporting to corresponding areas * Maintain excellent quality and productivity standards for all client programs complying with program scripts and guidelines * Accurately collect information required by individual programs and correctly capture in specific program databases * Exhibit excellent communication and tele-management skills
senior drug safety associate-global medical safety
the janssen pharmaceutical companies of johnson & johnson
* Global reporting of serious and nonserious adverse events from clinical trials and post marketing to the proper regulatory authorities. * Maintain, review, and analysis of reported serious and nonserious adverse events; evaluate the need and request for follow-up information * Request QA analysis per case basis and perform monthly reconciliation; Unblinding of clinical trial reports; Perform literature searches. * Problem solving ability to adjust to a changing environment in working with physicians in preparation of SUA reports. * Utilizing global database to enter cases, perform searches, and queries; perform manual coding with MEDRA as needed. Perform and evaluate adverse event reports in triage function in order to prioritize workload * Perform reconciliation of SAEs between safety and clinical database

adverse event specialist, safety department
theorem clinical research
* Report serious adverse events elicited from CRF review or telephone communication from investigational sites to client companies * Review, analysis, and evaluation of suspected adverse events, extrapolating information for narrative writing and summaries according to standard operating procedures and regulatory regulations. * Review CRFs, extract specific information for data clarification requests to initiate and complete the reconciliation process with clinical database * Experienced in studies involving cardiovascular, anti-infective, oncologic, mental health, pain management, muscle-skeletal clinical trials * Involvement in clinical drug trial startup activities with ongoing management of that trial

staff and charge nurse-cardiology interventional unit
hahnemann university hospital
* Care and recovery of patients post catherization, coronary stents, pacemakers, defibrillators, and angioplasties, involving expertise in arterial catheters. * Proficient electrocardiogram readings * Intravenous anti-arrhythmic and angina management/titration

charge and staff nurse-cardiology- interventional, congestive heart failure unit
medical college of virginia
* Care and management of heart failure and cardiomyopathy patients * Initiation of MI fast track, and coronary sheath removal programs. * Assist with certification, from cardiologist, in post intervention sheath removal, with initiation of femstop device.

staff nurse-cardio-thoracic step-down surgical unit
lancaster general health
* Care and management of patients post permanent, epicardial and transvenous pacemakers. * Care and management of patients on inotropic, and anti-arrhythmic drug therapies. * Care of post cardio-thoracic patients.
Education
millersville university of pennsylvania
nursing
pennsylvania college of health sciences
nursing
sharon mckeown's Contact Information
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