Recent Drug Safety and Pharmacovigilance Experience

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Recent Duties and Accomplishments

  • Conducted comprehensive PV diagnostic assessments, designed and implemented organizational and governance structures, advised on global SOP direction and development for several emerging BioPharma companies.
  • Global PV Lead at a mid-size biotech for the oversight of patient interactions from PSP activities and ensured appropriate PV provisions in all third-party agreements via SDEAs/PVAs.
  • Head of a Worldwide Drug Safety Office with oversight responsibilities for 65 DSOs and staff. Increased the overall quality of PV operations, morale, and competence of staff and vendors. Reduced global ICSR submission errors by more than 60% while improving on-time reporting to 98% on heavy PSP caseloads. Drove a 60% reduction in major and critical DSO/LSO CAPAs hitting the PSMF.
  • Led the turnaround and recovery of an underperforming PV & PQC/PTC operation at a blue chip pharmaceutical company. Directed staff of 35 to improve the accuracy of case investigations and reporting. Reduced case aging from 7 days to 1; improvement in compliance went to 100% from 55%.
  • Designed and delivered a comprehensive pharmacovigilance resource decision support tool to drug safety executives of a top 3 global pharma company to aid in determining and justifying appropriate staffing for EMEA, APAC, NA and LATAM Regions.
  • Chaired joint QA/GPV leadership and integral participant on an Executive Steering Committee to address and remediate to multiple FDA 483 findings.
  • Assumed responsibility for Worldwide Inspection Readiness efforts. Initiated global training programs and assembled proof books in advance of HA inspections resulting in significantly reduced findings.
  • Accountable for the setup, oversight, timely updates and delivery of the Pharmacovigilance System Master File (PSMF) to the EUQPPV.

Drug Safety Mind Set

Most development stage organizations do not yet possess a safety governance model, infrastructure to handle signal detection or worldwide reporting.  We can reduce this risk and help you setup a PV system quickly and without sacrificing quality.

Safety Governance Model Escalation