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Skills

  • Regulatory Compliance Analysis
  • Siemens Soarian Financials
  • QMSoftware Receivables Management
  • Knowledge of Microsoft Excel adverse reactions
  • Records review
  • Medical document accuracy
  • Operational improvement
  • FDA reporting compliance
  • Mentorship and training of junior staff
  • Interpretation of complex diagnoses

Work Experiences

  • Achieved a 33% reduction in reporting errors.
  • Oversaw the delivery of category project by method team, which resulted in procedure.
  • Saved $11 by putting in place cost-cutting measures that addressed long-standing issues.
  • Assisted in the development of standard operating procedures.
  • Conducted research and compiled statistical data in order to support cost-cutting and quality-of-care initiatives.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Achieved approval within 8 months.
  • Answered 11 calls per the past year to help customers with their questions and concerns.
  • Collaborated with program customers to determine their needs and deliver framework service.
  • Easily interacted and communicated with department personnel and the general public.

Summaries

  • Achieved President's Club recognition.
  • Achieved QuickBooks regulatory approval within 7 months.
  • Consistently improved review accuracy.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Conducted key regulatory reviews.
  • Accelerated case evaluation times by 52%.
  • Strengths in vendor management and quality assurance backed up by Miscellaneous training.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Achieved results within the past year.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.

Accomplishments

  • Developed and maintained tracking tools that reduced case review turnaround time by 58% and ensured real-time compliance with regulatory commitments.
  • Presented data-driven insights to stakeholders based on post-market surveillance data, leading to an organizational risk reduction of 22%.
  • Worked with a cross-functional team of 8 to address gaps in pharmacovigilance processes, achieving a compliance improvement of 82%.
  • Proposed new reporting workflows to seamlessly integrate FDA compliance checks, leading to a review cycle improvement of 15%.
  • Performed reviews of adverse event reports, including analysis of 7 submitted cases, to ensure timely and accurate reporting to regulatory bodies.
  • Coordinated with product safety teams to analyze post-market surveillance data and reduce adverse drug reactions by 73%, ensuring compliance with FDA standards.
  • Led quality assurance checks across reviewed safety data, facilitating the timely processing of 10 priority regulatory submissions.
  • Implemented system-wide updates to the pharmacovigilance process, resulting in a 54% improvement in case management efficiency.
  • Initiated collaborative safety signal detection procedures, bringing potential safety issues to attention 7 months sooner, supporting proactive risk management.
  • Developed and optimized algorithms to streamline adverse event coding, reducing manual input errors and improving accuracy by 74%, in adherence with ICD-10 standards.

Affiliations

  • International Association of Therapeutic Drug Monitoring & Clinical Toxicology (IATDMCT)
  • International Council of Nurses
  • Lions Club
  • American College of Healthcare Executives (ACHE)
  • Association for Computing Machinery
  • American Society of Health-System Pharmacists (ASHP)
  • American Association for the Advancement of Science (AAAS) - Health Sciences Chapter
  • Pharmaceutical & Biotech Professionals International Network (PBIN)
  • Drug Information Association (DIA)
  • Project Management Institute

Certifications

  • Data Standards & Reporting Certification - Clinical Data Interchange Standards Consortium (CDISC)
  • First Aid/CPR Certified
  • Certification in Health Care Compliance (CHC) - Summit Group
  • Certified Professional in Patient Safety (CPPS) - Northwind
  • SHRM Certified Professional (SHRM-CP)
  • CompTIA Network+
  • Health Care Quality and Safety Certificate - system
  • Salesforce
  • Certified Healthcare Privacy and Security (CHPS) - procedure
  • Certified Case Manager (CCM) - Beacon Labs

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