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Skills

  • Clinical Protocol Review and Validation
  • Product lifecycle management
  • Data-driven process improvements
  • Documentation for Risk Management
  • Budgets
  • NDCMedisoft
  • Team building
  • Supervision
  • Adverse Event Reporting
  • First Aid/CPR

Work Experiences

  • Addressed non-compliant elements early.
  • Used email and the phone to communicate effectively with staff, patients, and insurance companies.
  • Analyzed clinical AE reports, detecting trends that led to immediate corrective actions saving $26,000 in penalties.
  • Automated key elements of the review workflow, improving review times by 33% and reducing clerical errors.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Automated key elements of the review workflow.
  • Assessed safety concerns in post-marketing reports, leading to the timely implementation of 6 proactive risk mitigation strategies.
  • Addressed ambiguities in clinical summaries.
  • Chaired weekly review meetings with multidisciplinary teams ensuring safety assessment completion ahead of deadline by 61%.
  • Assessed safety concerns in post-marketing reports.

Summaries

  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Accomplished Medical Reviewer with extensive experience in collaborating with data management teams to resolve coding errors in clinical databases. Consistently met submission deadlines and provided expert feedback to ensure accuracy.
  • Astute Medical Reviewer known for conducting regulatory meeting presentations and securing approval for 6 new medication launches. Demonstrates strong cross-functional leadership and an ability to synthesize complex data for stakeholders.
  • Consistently exceeded regulatory submission deadlines.
  • Boosted compliance rates through meticulous safety data analysis.
  • Conducted regulatory meeting presentations.
  • Collaborative Medical Reviewer excelling in clinical protocol review.
  • Accomplished Medical Reviewer known for reducing error rates by 78%.
  • Accomplished Medical Reviewer known for reducing error rates by 61% through collaboration with cross-disciplinary teams. Successfully streamlined adverse event reporting processes and enhanced reporting accuracy within 6 months.
  • Conducted timely clinical protocol reviews.

Accomplishments

  • Partnered with cross-functional teams in pharmacovigilance and regulatory affairs to strategize risk management for Jira, ensuring compliance within procedure.
  • Utilized expert knowledge of drug labeling requirements to recommend updates, aligning reporting accuracy and market compliance for 6% of products.
  • Optimized the review process for clinical trial reports, reducing the average time to complete reviews by 34% with zero compromises in quality.
  • Monitored post-marketing safety data for ServiceNow, providing quarterly updates on emerging risks to regulatory bodies.
  • Managed safety reports per GVP and ICH guidelines, advising leadership on potential risks and strategic initiatives for 9 of medications.
  • Performed expert-level safety evaluations within post-marketing surveillance activities, resulting in 4 prompt risk mitigation actions for high-priority products.
  • Drafted critical risk management plans that were adopted across multiple trials, resulting in 34% reduction in adverse event reoccurrences.
  • Advised clinical teams on data consistency requirements for trial phase reporting, significantly optimizing output accuracy by 55%.
  • Reviewed clinical trial safety data for metric, leading to early identification of potential safety risks and execution of corresponding mitigation plans.
  • Responsible for overseeing the medical review for 11 clinical trial studies, ensuring all protocols adhered to established ICH and FDA guidelines.

Affiliations

  • Lions Club
  • Society of Women Engineers
  • Society for Risk Analysis (SRA)
  • Jaycees
  • Rotary International
  • Association of Information Technology Professionals
  • European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • Certified Professional Medical Auditor (CPMA)
  • Regulatory Affairs Professionals Society (RAPS)
  • International Council of Nurses

Certifications

  • Certified Professional in Healthcare Risk Management (CPHRM) - Meridian
  • FDA Clinical Investigator Training Certification - 2015
  • Certified in Healthcare Quality Management (CHCQM) - 2022
  • Google Certified Professional Cloud Architect
  • Certified Healthcare Auditor (CHA) - metric
  • Project Management Professional (PMP)
  • ICH E6 for Clinical Investigators by system
  • Certified Professional in Regulatory Affairs (RAC) - initiative
  • Apple Certified Associate (ACA)
  • SHRM Certified Professional (SHRM-CP)

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