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Click here or scroll down to respond to this candidateCandidate's Name , RNStreet Address Crestwood Road Phone: PHONE NUMBER AVAILABLERockaway, NJ Street Address Email: EMAIL AVAILABLEHealthcare ProfessionalAn innovative and seasoned Registered Nurse/ Pharmaceutical professional with over two decades of clinical research experience including direct pharmaceutical industry experience in Pharmacovigilance and Quality Assurance. Outstanding ability to analyze, write, evaluate and produce detailed reports on a variety of projects including protocols and clinical study reports. Experienced working in Quality with technical complaints/ CAPAAs. Effective organizational, communication and time management skills . Thorough understanding of key ethical and regulatory issues.Areas of ExpertiseArgus 7.0.5ICD-9 & CPT Coding SpecialistOracle- Phase ForwardMedWatchMedDRA CodingBLS / ACLS certifiedAssisTekTrack WiseWord, Excel, OutlookMedidata-RaveEDC systems proficientSAPProfessional ExperienceBayer Healthcare, Morristown, NJ 2016-PresentSr Complaint Coordinator, Quality Assurance, Technical Complaints- PharmaceuticalsCase Processing, including triage of cases, review of investigations, review of medical evaluations, creation of letters to complainants and 3rd party companies.Assign appropriate risk classification after review of all relevant case information.Interfaces with internal/external call centers and complainants as required to obtain complete case information and investigate thoroughly.Supports internal and external inspections by providing subject matter expertise to department management.Identifies best practices and continuous improvement recommendations relating to processes, SOPs, Guidance documents, training and technology.Continuously monitors assigned products to assess trends and signal detection of a potential quality defect based on market feedback.Training of new departmental employees on internal complaint possesses, product knowledge and IT systems.Bayer Healthcare, Whippany, NJ 2013-2016SAFETY DATA SPECIALIST, PHARMACOVIGILANCE- Consumer CareActed as the project lead for a special project, which involved reviewing of all incoming reports to ensure reportability of adverse eventsInvolved in Bayer/Merck integration process. Facilitated and actively participated in process and database integration and improvement initiative working closely with cross-functional taskforces and committees. Performed new hire QC of off-site associates and provided feedback, when neededResponsible for managing group emailbox, assigning incoming questions and/or tasks to appropriate individuals/teamsPerformed QC of the not routed reports for Onsite and offsite cases on a daily basis and ensured all the reportable cases were routed, so as to adhere to timelines.Manage Argus safety database work lists according to global database documentation requirements and local Standard Operating ProceduresReview case information received from various sources for accuracy to ensure quality of data entry into global safety database.Collaborate with Consumer Relations to issue case clarifications and case corrections as neededPerform triage and MedDRA coding of serious and non-serious Adverse Event Reports according to local Standard Operating ProceduresPrioritize and accurately perform data entry for both serious and non-serious adverse event reports into the Argus safety affiliate database per departmental guidelines.Monitored, requested and obtained all applicable follow-up information from reporters to ensure completion of case reports within specified timelines as prescribed by global regulations and Standard Operating ProceduresEXODON CLINICAL RESeARCH, Mt. Arlington, NJ 2012 2013Clinical Research Nurse/CoordinatorNursing staff member charged with managing and coordinating clinical research studies.Managed studies to ensure compliance with study protocols, research objectives, informed consent and institutional guidelines. Collected and prepared study documents, including case report forms, other study related source documents as well as AE/SAE reports.Managed process associated with safety reportingPerformed study evaluations, controlled medication inventory, dispensed test pharmaceuticals, and assisted investigators in study management.Forecasted and maintained adequate clinical suppliesInterfaced directly with test subjects informing them about study elements and expectations.Ensured clinical trials were conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, and internal Standard Operating ProceduresUNIVERSITY OF MEDICINE AND DENTISTRY, Newark, NJ 1996 2011Clinical Research Nurse/CoordinatorNursing staff member charged with managing and coordinating clinical research studies.Collaborated with principal investigator on Womens Health Initiative Research to facilitate and coordinate daily clinical trial activities and implementation of study protocols. Performed nursing assessments, monitored subjects, and oriented other research staff to ensure proper compliance with federal regulations and institutional guidelines / code of conduct.Supervised research samples, records and essential documentation for multiple clinical studies; obtained and processed fluid samples, curated HIPAA records, maintained test subject charts and data sheets.Briefed test subjects about study elements and expectations.Maintained adequate and accurate case histories for each study subject and recorded all observations in the source document and on the Case Report Form (CRF) during a studyConsistently reviewed and assured compliance with all applicable Food and Drug Administration (FDA) Federal Regulations, the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practices (GCPs), health system policies, and site and protocol specific requirements.Designed and maintained organizational tools to conduct the study accurately and in compliance with GCPEducationBachelor of Science (in-progress), Perdue Global University, Davenport, IAAssociate Degree Applied Science, County College of Morris, NJLicensesRegistered Professional Nurse (license #26NO11881400)Volunteer Vice Presedent Randolph Board of Health 2011-Present |
