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Skills

  • Cross-functional team collaboration
  • Medical Literature Review
  • Corrective actions
  • Case Processing Management
  • Protocol development
  • Materials inspections
  • Drug Safety Reporting (DSR)
  • Patient Safety Data Tracking
  • Database Error Reduction Techniques
  • Regulatory compliance

Work Experiences

  • Achieved a 34% reduction in case entry error rates.
  • Achieved resolution ahead of key milestone dates.
  • Achieved 12 successful approvals with key health authorities.
  • Assisted in the automation of routine case processing tasks using ServiceNow, leading to a time-saving of standard for the team.
  • Collaborated in risk communication strategies.
  • Achieved a 78% reduction in case-handling discrepancies.
  • Checked the quality of raw materials and finished products and discarded anything that didn't meet safety standards.
  • Analyzed reoccurring patterns in ICSRs across 6 countries, supporting the redesign of pharmacovigilance workflows that improved signal thresholds significantly.
  • Analyzed reoccurring patterns in ICSRs across 9 countries.
  • Achieved results in 2018.

Summaries

  • Achieved optimized safety surveillance across Asana.
  • Within Miscellaneous, senior Pharmacovigilance Analyst and outstanding performer in project management and process improvement.
  • Proven experience working directly in QA and QC functions in the metric industry, with a strong understanding of general practices.
  • 16 years of experience in adverse event reporting.
  • Adept at cross-functional team management.
  • Achieved a 30% decrease in incorrect reporting.
  • Achieved a 36% accuracy rate.
  • Collaborative leader adept at influencing risk management strategies by delivering detailed safety analytics and generating data-driven insights for 14 global clinical trials.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.

Accomplishments

  • Trained 7 new employees on pharmacovigilance protocols, increasing team efficiency by 78% and reducing processing errors.
  • Analyzed trends in global safety data, leading to a key safety alert that helped prevent 6 serious adverse events related to process.
  • Identified critical safety signals by analyzing adverse event reports, which prompted immediate safety protocols, reducing reported incidents by 26% for framework.
  • Successfully managed post-marketing pharmacovigilance activities, providing valuable safety insights which contributed to the safe ongoing distribution of SAP.
  • Performed critical medical literature reviews, flagging relevant adverse event data used in 16 drug safety assessments.
  • Documented and resolved framework which led to standard.
  • Created safety monitoring dashboards which provided real-time insights, enabling prompt responses to emerging drug safety issues and enhancing risk management efficiency.
  • Created and maintained detailed Standard Operating Procedures (SOPs) to ensure compliance with regulatory guidelines, improving overall process consistency for 16 departments.
  • Coordinated safety data across various clinical trials, ensuring data integrity and improving the accuracy of global adverse event records by 76%, directly contributing to product safety evaluations.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.

Affiliations

  • American Society for Clinical Pharmacology & Therapeutics (ASCPT)
  • Japan Society for Clinical Pharmacology and Therapeutics (JSCPT)
  • Association for Computing Machinery
  • American Society of Safety Professionals
  • Pharmaceutical Product Safety Network (PPSN)
  • Regulatory Affairs Professionals Society (RAPS)
  • International Conference on Harmonisation (ICH) Expert Working Group
  • International Council of Nurses
  • Toastmasters
  • American College of Clinical Pharmacology (ACCP)

Certifications

  • Clinical Trial Management Certification - Lakeside Partners
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Good Pharmacovigilance Practices (GVP) Professional - Harbor & Co.
  • Google Certified Professional Cloud Architect
  • Safety Signal Detection and Management Certification - Beacon Labs
  • Certified Public Accountant
  • Certified Healthcare Risk Management Professional (CHRMP) - program
  • FDA’s Good Pharmacovigilance Practices and Pharmacoepidemiology Training - 2024
  • Advanced Drug Safety and Pharmacovigilance - Northwind
  • SHRM Certified Professional (SHRM-CP)

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