EXPERIENCE

Clinical Risk Management Scientist
Confidential
February 2011 to Present (contract position)

• Drafts/authors regulatory documents/submissions or external company responses such as Periodic Safety Update Reports, expert statements, responses, Risk Management Plans
• Participates in Clinical Risk Management product-specific and team meetings
• Performs ongoing monitoring and review of data through regularly scheduled or ad hoc query requests
• Participates in post-marketing safety signal evaluation strategy for assigned products
• Assists with the development and evaluation of pharmacovigilance and risk management plans
• Assists with quality control of prepared responses
• Utilizes information technology skills in the identification and clinical interpretation of safety signals
• Provides evaluation of seriousness, expectedness/listedness, trend analysis.
• Participates in Spotfire User Acceptance Testing (including scenario development), PSUR Quality Assurance pilot program, other product and non-product process-related support activities (e.g., case classification, process harmonization initiatives)

Project Associate, Document Quality & Management
Confidential
February 2009 to February 2011 (contract position)

• Responsible for ensuring the overall quality of key deliverable documents such as PSURs, Summary Bridging Reports, RMPs, Clinical Overviews, ad hoc responses, Health Hazard Evaluations, and Safety Surveillance Reports
• Provided editorial and technical/publishing review and formatting of documents for regulatory submission; tracking of document workflow through MS Project
• Provided in-process quality control review including data accuracy, adequate statement of the issue, logical scientific flow, description of strategy/methodology, document organization, readability, language, grammar/syntax, and consistency with J&J, GMS, and AMA style guidelines.
• Served as Lead PSUR reviewer, representing Document Quality & Management at pre-PSUR planning and post-PSUR quality/method assessment meetings.
• Participated in quality review process initiatives and assisted with controlled document development through quality review of SOPs, policies, work instructions and guidelines
• Monitored review comments and source data (including electronic case report forms [eCRFs], SAS JMP output, Excel spreadsheets and pivot tables, surveillance reports, exposure reports, trend analyses, core data and other reference safety information, CIOMS and MedWatch reports, etc.) as a means of quality improvement.
• Provided departmental training; authored and implemented training and reference manual for document quality consultants/project associates.
• Assisted in departmental quarterly budget planning and management/scheduling of document assignments.

Adverse Event/Drug Safety Specialist
Confidential
September 2008 to January 2009 (contract position)

• Provided case processing of adverse event reports for investigational and marketed products, including authoring of case summaries, follow-up phone calls/communication to healthcare professionals
• Participated in special projects (assessment of adverse events for community-acquired pneumonia multivalent vaccine)
• Experienced in safety database, MedDRA coding, EDMS, eCRFs

Legal Nurse Consultant (pharmaceutical)
Confidential
September 2006 to September 2008 (contract position)

• Legal defense experience in pharmaceutical and medical product liability litigation for hormone replacement/oncology and PPA cases at global to-15 law firm
• Reviewed medical records, plaintiff fact sheets, legal and other documents
• Prepared/authored case summaries and analyses, medical chronologies and comprehensive case workup.
• Assisted attorneys with discovery process

Legal Nurse Consultant (pharmaceutical & medical devices)
Confidential
November 2004 to August 2006 (staff position)

• Legal defense experience in pharmaceutical and medical product liability litigation for antipsychotic medications, vascular stents and other devices, and personal injury and medical malpractice litigation for corporate at top national law firm
• Reviewed medical records, plaintiff fact sheets, legal and other documents
• Prepared/authored case summaries and analyses, medical chronologies and comprehensive case workup.
• Assisted attorneys with discovery process
• Participated in special projects (adverse event reports, review/redaction of pharmaceutical call notes, case/precedent research activities)
• Developed and implemented a paralegal/legal nurse consultant training program and training manual.

Record Review Nurse (pharmaceutical litigation)
Confidential
August 2003 to November 2004 (ad hoc staff position)

• Provided review and analysis of medical records
• Audited cases for trust established and directed by Federal court for the administration and settlement of mass tort claims in diet drug litigation
• Assessed complex claims packets and supportive medical records for eligibility criteria and determination of injury level and payment matrices.

Contract/Per Diem Nurse
Confidential
2000 to August 2003 (miscellaneous per diem assignments)

• HEDIS (Health Plan Employer Data and Information Set) medical record review and data assessment
• Case management in pre-certification department of managed healthcare company
• Clinical nursing in critical care, emergency room and long-term care settings.

Nursing Supervisor
Confidential
1993 to 1995 (staff position)

• Supervised 6-10 nurses and 15-25 nursing assistants at 180-bed long-term care facility for geriatric and Alzheimer's patients; prepared staff assignments
• Served as sole medical/nursing professional on evening/night shift
• Provided clinical assessment, emergency care, wound care, administration of intravenous medications
• Experienced in Medicare procedures and documentation
• Provided staff in-service training programs, employee counseling/conflict resolution and disciplinary action, new-hire interviews

Nursing Supervisor
Confidential
1990 to 1993 (staff position)

• Supervised 10-15 nurses and 20-40 nursing assistants/personal care aides at combination 275-bed long-term care/130-bed assisted-living facility for geriatric and Alzheimer's patients; prepared staff assignments
• Served as sole medical/nursing professional on evening/night shift
• Provided clinical assessment, emergency care, wound care, administration of intravenous medications
• Experienced in Medicare procedures and documentation
• Provided staff in-service training programs, employee counseling/conflict resolution and disciplinary action, new-hire interviews

Charge Nurse
Confidential
1987 to 1989 (staff position)

• Supervised 6-8 nurses, 2 telemetry monitor technicians, 2 unit clerks on 10-bed acute coronary care unit; prepared staff assignments
• Experienced in hemodynamic monitoring, mechanical ventilation, intra-aortic balloon pump counterpulsation, peritoneal dialysis
• Assisted physicians with fluoroscopic procedures
• Member of hospital code response team
• Member of hospital Quality Assurance Committee
• Participated in house staff training programs and Nurse Mentoring Program
• Critical care, intravenous line and arterial line certified.

Registered Nurse
Confidential
1986 to 1987 (staff position)

• Experienced in telemetric monitoring, care of medical and surgical cardiopulmonary patients including heart- and lung-transplant, mechanical ventilation
• Trauma and intravenous line certified
• Served as nursing staff mentor

SKILLS

• Excellent assessment, organizational, communication and computer skills
• Proficiency in MS Word, MS Office, MS Excel, MS Outlook, MS Project, safety surveillance databases, DocsOpen, SharePoint, Novell, EDMS, QlikView, Documentum and other document repositories, MS PowerPoint, Concordance, Summation, electronic libraries.
• Proficiency with medical terminology and MedDRA coding.
• Experience in writing, proofreading and editing for publications (with worldwide distribution) of international electronics organization.
• Participation in continuing education and professional growth programs including nursing, pharmacology, and adverse event reporting.

PROFESSIONAL LICENSURE/AFFILIATIONS/ACADEMIC ACHIEVEMENTS

• Registered Nurse
• Member Alpha Eta Honor Society for Allied Health Professionals
• Member American Association of Legal Nurse Consultants
• Member, American Nursing Association
• Member, American Society of Registered Nurses
• Member, American Association of Critical-Care Nurses
• Member, Hahnemann University Hospital Quality Assurance Committee
• Dean's List, Hahnemann University (all semesters)
• Board of Directors/Newsletter Editor

EDUCATION
BS, Health Administration
AS, Nursing