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Skills

  • Relationship development
  • Compliance with Good Pharmacovigilance Practices (GVP)
  • Project organization
  • Performance testing
  • Budgets
  • Data quality assurance in adverse event reporting
  • Interdisciplinary teamwork with regulatory and clinical teams
  • Team building
  • Operations monitoring
  • Benefit-risk assessment

Work Experiences

  • Contributed to a 79% decrease in observed safety incidents.
  • Aligned pharmacovigilance processes.
  • Conducted Risk Evaluation for key products.
  • Achieved improvements in 2015.
  • Conducted a visual inspection of products to determine if they met quality standards.
  • Collaborated across 15 global affiliates to align pharmacovigilance processes, improving adverse event reporting times by 69%.
  • Achieved a 37% reduction in data discrepancies.
  • Achieved approvals across 3 markets.
  • Awarded in 2016.
  • Built relationships with affiliate offices.

Summaries

  • Collaborated with clinical trials.
  • In system environments, a hardworking Pharmacovigilance Specialist who is knowledgeable about sampling and testing procedures.
  • Proven experience working directly in QA and QC functions in the process industry, with a strong understanding of general practices.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Collaborative safety oversight.
  • Ready to put 2 years of experience to work in order to meet metric quality control goals.
  • Extensive testing of incoming materials, components, and finished products is second nature to me.
  • Bringing unrivaled technical troubleshooting and data interpretation expertise gained over 14 years of experience.
  • Conducted meticulous safety monitoring.
  • Pharmacovigilance Specialist is a multi-talented Pharmacovigilance Specialist who is consistently rewarded for planning and operational improvements.

Accomplishments

  • Played a key role in preparing for method regulatory inspections, ensuring all pharmacovigilance data was audit-ready without findings.
  • Regularly reviewed and presented PV metrics to senior management, influencing decisions related to drug safety for system.
  • Spearheaded the automation of signal detection workflows using SAP, improving early detection of safety issues by 32%.
  • Developed safety management and monitoring framework during Phase II clinical trials, leading to timely identification of 15 significant safety concerns.
  • Collaborated with team of 14 in the development of procedure.
  • Led a pharmacovigilance audit prep team, leading to zero critical findings in a 2019 FDA inspection and improving process adherence by 70%.
  • Collaborated with cross-functional teams in the development of safety signal management strategies, addressing 9 key safety concerns.
  • Implemented a quality improvement plan for adverse event reporting, which increased compliance with global safety regulations by 30%.
  • Contributed to cross-departmental safety data exchange improvement projects, significantly reducing AE under-reporting by 82%.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.

Affiliations

  • Membership in the American Society for Clinical Pharmacology and Therapeutics (ASCPT)
  • International Association of Administrative Professionals
  • Post-market Surveillance and Safety Committee Member, Chicago
  • Working Group on Signal Management Essentials - WHO Uppsala Monitoring Centre
  • Society of Women Engineers
  • American Marketing Association
  • International Conference on Harmonisation (ICH) GCP E6 Guidelines Working Group
  • Adverse Drug Reactions (ADR) Monitoring Forum
  • Society of Human Resource Management
  • Health Technology Assessment International (HTA International)

Certifications

  • Certified in Global Safety Reporting Regulations from standard
  • Certified Public Accountant
  • SHRM Certified Professional (SHRM-CP)
  • Cisco Certified Internetwork Expert (CCIE)
  • Salesforce
  • Pharmaceutical Safety and Risk Management Certificate from Cedar Works
  • Regulatory Affairs Certification (RAC) from category
  • Certified Pharmacovigilance Professional (CPP) from program
  • CompTIA Network+
  • Compliance with Medicines and Healthcare Products Regulatory Agency (MHRA) Standards

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