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Skills

  • Communications
  • Biological risk assessment
  • MS Office
  • System analysis
  • Problem resolution
  • Customer service
  • Business operations
  • Advanced understanding of GVP modules
  • Clinical trial safety data management
  • Testing procedures

Work Experiences

  • Consolidated global ICSR data into aggregate summary reports.
  • Collaborated with the clinical safety team to streamline case processing workflows, reducing manual data entry errors by 68%.
  • Technical documents such as deviation reports, testing protocols, and trend analyses were all written by me.
  • Assessed and triaged adverse reactions using Asana, ensuring a 66% reduction in processing time for serious events.
  • Completed data capture forms, equipment logbooks, and inventory forms as part of the testing procedures documentation.
  • Collaborated with external partners.
  • Conducted inspections throughout 2021.
  • Provided project updates and consultation as a liaison between quality control and other departments and contractors.
  • Championed case data migration from legacy systems to ServiceNow.
  • Acted as a primary point of contact for external vendors.

Summaries

  • Bringing unrivaled technical troubleshooting and data interpretation expertise gained over 6 years of experience.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • 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.
  • Clear understanding of risk assessment and client relations as well as team leadership training.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Pharmacovigilance Associate is a multi-talented Pharmacovigilance Associate who is consistently rewarded for planning and operational improvements.
  • Adept at consolidating pharmacovigilance data.
  • Aligned submissions with global regulations.
  • Achieved zero significant findings across 3 audits.

Accomplishments

  • Provided pharmacovigilance support during 5 Health Authority inspections, with zero critical findings in post-audit analysis conducted in 2017.
  • Developed and maintained risk management plans for framework, driving cross-functional alignment and contributing to product safety improvements.
  • Mentored junior associates in case processing, significantly improving timely submissions and overall department efficiency.
  • Assumed responsibility for completing Individual Case Safety Reports (ICSRs) within 84% of required timelines, reducing backlog by 62%.
  • Supported periodic risk-benefit review meetings for Workday, influencing strategic decisions on risk minimization measures.
  • Streamlined case processing workflows using SAP, achieving a 26% reduction in case handling time for serious safety events.
  • Collaborated with team of 6 in the development of initiative.
  • Led initiatives to enhance MedDRA coding accuracy, resulting in 56% fewer discrepancies in data classification during audits.
  • Collaborated with cross-functional teams to analyze and classify adverse events, resulting in a 37% improvement in data accuracy and compliance.
  • Presented pharmacovigilance data to senior leadership, influencing regulatory submissions and risk management plans tailored to initiative or the Southeast's specific requirements.

Affiliations

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
  • International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
  • European Forum for Good Clinical Practice (EFGCP)
  • World Drug Safety Congress
  • Association for Supply Chain Management (APICS)
  • American Marketing Association
  • International Society of Pharmacovigilance (ISoP)
  • Association for Computing Machinery
  • International Association of Therapeutic Drug Monitoring & Clinical Toxicology (IATDMCT)
  • American College of Clinical Trial Investigators

Certifications

  • Cisco Certified Network Associate (CCNA)
  • Case Processing Workflow Optimization Certification, method
  • Certified Risk Evaluation and Mitigation Strategies (REMS) Manager, category
  • Advanced Pharmacovigilance and Drug Safety, program
  • MedDRA Coding Certification, framework
  • CompTIA Security+
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Medical Writing Certification, process
  • Advanced Signal Detection and Management, initiative
  • Certified Public Accountant

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