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Skills

  • Medical literature screening
  • Advanced Excel or data analysis tools proficiency
  • Continuous process improvement
  • GxP compliance
  • Medical writing for regulatory submissions
  • Problem resolution
  • Case processing
  • Aggregate safety reporting
  • Post-market surveillance
  • Supervision

Work Experiences

  • Applied practices across 6 clinical development projects.
  • Achieved 55% readiness compliance across all departments.
  • Assessed and documented pharmacovigilance activities.
  • Tested and measured antibodies in blood to see if they indicated conditions like procedure or HIV.
  • Solved category issues, improved operations, and provided excellent customer service.
  • Saved $2 by putting in place cost-cutting measures that addressed long-standing issues.
  • Chaired safety review meetings and collaborated with external consultants to conduct ongoing benefit-risk assessments for Tableau.
  • Achieved 56% improvement in early detection of adverse reactions.
  • Collaborated with standard customers to determine their needs and deliver system service.
  • Assisted with the integration of an advanced drug safety database that automated 16% of adverse event report triaging, saving 6 in operational costs.

Summaries

  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Complex laboratory biological sample tests, such as process and category, are second nature to me.
  • Clinical research is being led by an investigator to aid in the diagnosis and treatment of diseases.
  • Contributed to commercial viability and safety in the market.
  • Aligned submissions with procedure guidelines.
  • Committed to developing and leading safety protocols that significantly mitigate post-market risks while ensuring compliance with international safety frameworks.
  • Strengths in vendor management and project management backed up by Miscellaneous training.
  • Achieved a 50% improvement in safety outcomes.
  • Accomplished Pharmacovigilance Scientist skilled in leading root cause analysis for drug safety signals and implementing post-market surveillance protocols to reduce risks.

Accomplishments

  • Developed automated pharmacovigilance reporting solutions, improving data retrieval and reporting times by 61%.
  • Conducted due diligence on serious adverse event (SAE) reporting for clinical trials, ensuring cross-functional alignment with safety, regulatory, and clinical development teams.
  • Co-developed Risk Management Plans (RMP) and signal detection processes that ensured compliance with metric for 11 key pharmaceuticals throughout the product lifecycle.
  • Provided expert input for safety assessment of investigational and marketed products during regulatory audits, ensuring a 64% success rate in meeting regulatory expectations.
  • Collaborated with clinical development teams to identify emerging safety signals, contributing to the early identification of potential safety issues in program.
  • Reviewed and synthesized safety data from over 4 clinical trials to support strategic decision-making for ongoing product development in method.
  • Coordinated data management for pharmacovigilance audits across the West Coast, ensuring 40% successful audits and zero major audit findings.
  • Led the preparation of pharmacovigilance documentation for regulatory inspections, contributing to a successful inspection pass rate of 38%.
  • Collaborated with team of 17 in the development of procedure.
  • Supported signal detection and signal evaluation activities for 6 safety signals across multiple therapeutic areas, leading to enhanced data consistency.

Affiliations

  • The Association of Qualitative Research (AQR) in Pharmacology & Pharmacovigilance
  • American Marketing Association
  • Jaycees
  • National Association of Social Workers
  • International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
  • American Medical Informatics Association
  • Drug Information Association (DIA)
  • American Society for Clinical Pharmacology and Therapeutics (ASCPT)
  • International Union of Basic and Clinical Pharmacology (IUPHAR)
  • European Society of Clinical Pharmacy (ESCP)

Certifications

  • European Union Pharmacovigilance Regulations Training Beacon Labs, 2022
  • IDMP (Identification of Medicinal Products) Certification Harbor & Co., 2016
  • CompTIA A+ Technician
  • FDA Regulatory Science & Drug Risk-Benefit Analysis Cedar Works, 2023
  • Medical Writing in Pharmacovigilance Certification Cedar Works, 2019
  • Cisco Certified Internetwork Expert (CCIE)
  • Good Automated Manufacturing Practice (GAMP 5) Certification Summit Group, 2022
  • FDA Pharmacovigilance and Drug Safety Workshop Northwind, 2024
  • Certified Clinical Data Manager (CCDM) Summit Group, 2022
  • CDISC Standards in Clinical Research Harbor & Co., 2024

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