Seasoned Clinical Research & Drug Safety Leader

Experienced pharmacovigilance consultant and PV leader with 26 years of pharma and CRO experience leading global teams in Americas, EU and Asia/Pacific regions. Has a unique combination of sponsor and vendor experience. Able to provide submission preparation analysis (2.7.4/ISS, 2.5. label, review of ISI) along with other pharmacovigilance data analysis (e.g. Safety Review Committees, Data Monitoring Committees). Specializes in bringing small companies to a higher state of compliance including writing SOPs, processes, and develop training programs for small organizations who are in “start-up” mode.

Relevant Therapeutic Areas

  • Infectious diseases
  • Vaccines
  • Oncology
  • Allergy / Immunology
  • Autoimmune / Inflammation
  • Cardiovascular Diseases
  • Hematology

Product Technologies

  • Biologics
  • Cell Therapies
  • Monoclonal Antibodies
  • Small Molecule
  • Vaccines

Recent Titles

  • Vice President, Drug Safety
  • Executive Director, Global Head of Pharmacovigilance


  • Mid-Atlantic Area
  • Open to remote, in-office, and travel

Relevant Companies

  • Covance
  • Kyowa Kirin
  • Wyeth
  • Small Biotechs

Skills & Accomplishments

  • Member of multiple Safety Assessment Committees (SACs), reviewing unblinded client safety data for the purposes of signal detection and evaluation, expedited reporting, and oversight of study-level DSMBs.
  • Voting member of Global PV Committee, and Western PV Operations Leader for a global pharmaceutical company.
  • Created process, wrote SOP, and currently oversees process for Development Safety Update Reports (DSURs).
  • Aligned processes (SOPs and Work Instructions) for an integrated Western Safety organization.
  • Created process, wrote SOP and process for expedited submissions.
  • Participates in review of Informed Consent Forms (ICFs), Investigator Brochures (IBs), Integrated Summaries of Safety (ISS).