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Skills

  • Continuous process improvement
  • Cross-functional collaboration
  • Root cause analysis
  • MS Office
  • Regulatory submission support
  • Team management
  • Pharmacovigilance inspections readiness
  • Case processing
  • Pharmacovigilance software tools proficiency
  • Budgets

Work Experiences

  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Analyzed post-market safety data for 26% improvement in the early detection of adverse reactions in phase IV clinical trials.
  • Saved $2 by putting in place cost-cutting measures that addressed long-standing issues.
  • Had an excellent attendance record and was always on time for work.
  • Collaborated with cross-functional teams.
  • Researched and studied the physiology and health conditions of animals and humans.
  • Analyzed over 13+ cases.
  • Collaborated with global regulatory authorities to ensure the appropriate classification and re-escalation of pharmacovigilance signals for category.
  • Presented the results of my research to a scientific audience as well as the general public.
  • Assisted with the integration of an advanced drug safety database that automated 16% of adverse event report triaging, saving 6 in operational costs.

Summaries

  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Within Miscellaneous, senior Pharmacovigilance Scientist and outstanding performer in project management and stakeholder engagement.
  • Adept at managing drug safety databases and optimizing adverse event triaging, saving 2 in operational costs and improving overall case processing efficiency.
  • Committed to developing and leading safety protocols that significantly mitigate post-market risks while ensuring compliance with international safety frameworks.
  • Adept at contributing scientific input on pharmacovigilance procedures during regulatory submissions, influencing critical product approval decisions.
  • Conducted pre-approval meetings with regulatory bodies.
  • Conducted long-term safety evaluations for biopharmaceutical products.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the category business.
  • Aligned submissions with procedure guidelines.
  • Conducted adverse event analysis.

Accomplishments

  • Developed automated pharmacovigilance reporting solutions, improving data retrieval and reporting times by 61%.
  • Provided expert input for safety assessment of investigational and marketed products during regulatory audits, ensuring a 64% success rate in meeting regulatory expectations.
  • Reviewed and synthesized safety data from over 4 clinical trials to support strategic decision-making for ongoing product development in method.
  • Optimized pharmacovigilance workflows, reducing adverse event case processing times by 43% through the adoption of Workday and best practices.
  • Reviewed over 8 Periodic Benefit-Risk Evaluation Reports (PBRER) ensuring compliance with global regulatory requirements and providing actionable safety insights for future clinical programming.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Assisted in adverse event coding and reporting, overseeing a 44% improvement in adherence to regulatory submission timelines across top-level clinical programs in Raleigh.
  • Developed and implemented a streamlined process for Individual Case Safety Reports (ICSRs) leading to a 71% increase in accuracy and efficiency of case processing times.
  • Implemented a signal management process that increased early signal detection by 77% and improved responsiveness to safety concerns in procedure.
  • Coordinated data management for pharmacovigilance audits across the West Coast, ensuring 40% successful audits and zero major audit findings.

Affiliations

  • Public Responsibility in Medicine and Research (PRIM&R)
  • Society of Toxicology (SOT)
  • Freemason
  • Jaycees
  • Regulatory Affairs Professionals Society (RAPS)
  • National Association of Social Workers
  • International Council of Nurses
  • American Society of Safety Professionals
  • American Pharmacists Association (APhA)
  • Rotary International

Certifications

  • Apple Certified Associate (ACA)
  • Good Automated Manufacturing Practice (GAMP 5) Certification Summit Group, 2022
  • Cisco Certified Internetwork Expert (CCIE)
  • CompTIA Network+
  • First Aid/CPR Certified
  • FDA Pharmacovigilance and Drug Safety Workshop Northwind, 2024
  • ICH E6(R2) GCP Investigator Site Training Brightline, 2015
  • EudraVigilance Training Course (EVWEB) Cedar Works, 2017
  • Certified Pharmacovigilance Auditor Vantage, 2021
  • Good Pharmacovigilance Practices (GVP) Training Vantage, 2015

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