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Skills

  • Multilingual proficiency in Japanese
  • MedDRA coding
  • Clinical safety team collaboration
  • Global Individual Case Safety Reports (ICSR) management
  • Technical troubleshooting
  • First Aid/CPR
  • Clinical trial safety data management
  • Budgets
  • Literature case management
  • Supervision

Work Experiences

  • Identified the root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout the product development process.
  • Documented and executed detailed test plans and test cases, as well as summarized and logged audit findings for reporting purposes.
  • Acted as a primary point of contact for external vendors, overseeing pharmacovigilance activities to ensure adherence to safety and regulatory frameworks.
  • Assessed and triaged adverse reactions using Asana, ensuring a 66% reduction in processing time for serious events.
  • Gathered and organized test data in preparation for the creation and analysis of reports.
  • Collaborated with external partners and managed pharmacovigilance agreements, ensuring global consistency across 13 markets.
  • Collaborated with the medical team.
  • Consolidated global ICSR data into aggregate summary reports.
  • Collaborated with the medical team to conduct causality assessments on adverse events, optimizing data accuracy by 32%.
  • Checked the quality of raw materials and finished products and discarded anything that didn't meet safety standards.

Summaries

  • Ready to put 3 years of experience to work in order to meet program quality control goals.
  • To conduct experiments successfully, pays close attention to detail and uses critical reasoning.
  • Experienced Quality Control Analyst with a track record of using hands-on inspections, testing methods, and data analysis to improve products and procedures.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Strong experience collecting and analyzing quality metrics as well as making recommendations for process and quality improvement.
  • Boosted team data accuracy by 54%.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the category business.
  • Accomplished in developing pharmacovigilance procedures and SOPs for adverse event reporting, successfully reducing reporting timelines by 77% and ensuring global regulatory compliance.
  • Achieved a 73% improvement in pharmacovigilance efficiency.
  • Adept at aligning adverse event reporting procedures.

Accomplishments

  • Developed and maintained risk management plans for framework, driving cross-functional alignment and contributing to product safety improvements.
  • Partnered with program to develop and standardize pharmacovigilance reporting tools across multiple country platforms, improving global functionality by 28% %.
  • Monitored safety data and identified signals that led to 12 potential safety-related recommendations to the regulatory team.
  • Worked closely with regulatory affairs teams to provide high-quality data used in crucial safety labeling changes for method across 18 countries.
  • Assessed and triaged serious and non-serious adverse event cases, preventing delays in submission during critical product launch periods.
  • Supported periodic risk-benefit review meetings for Workday, influencing strategic decisions on risk minimization measures.
  • Reduced serious adverse event backlog by 78% after implementing an accelerated report prioritization process using Adobe Creative Suite.
  • Conducted thorough causality assessments for 17 adverse event reports using Salesforce, ensuring consistent and reliable data in compliance with global guidelines.
  • Ensured successful completion of regulatory submissions for adverse drug reactions (ADRs) and helped the organization achieve a Excellence Award from system.
  • Mentored junior associates in case processing, significantly improving timely submissions and overall department efficiency.

Affiliations

  • American Society of Safety Professionals
  • American Marketing Association
  • International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
  • International Society of Pharmacovigilance (ISoP)
  • American College of Clinical Pharmacology (ACCP)
  • Association for Supply Chain Management (APICS)
  • Council for International Organizations of Medical Sciences (CIOMS)
  • Society for Clinical Research Sites (SCRS)
  • American Society for Pharmacovigilance (ASP)
  • Global Pharmacovigilance and Risk Management Summit

Certifications

  • Cisco Certified Network Associate (CCNA)
  • Certified Regulatory Affairs Specialist, Pharmacovigilance Focus
  • Comprehensive ICSR Management Certification, 2017
  • Pharmacovigilance Training, process 2018
  • Advanced Pharmacovigilance and Drug Safety, program
  • CompTIA Security+
  • Apple Certified Associate (ACA)
  • ISO/IEC 27001 Information Security Certification, Focus on Healthcare and Safety Data
  • CompTIA A+ Technician
  • Certified Professional in Pharmacovigilance (CPP), initiative

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