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 withh 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
- Allergy / Immunology
- Autoimmune / Inflammation
- Cardiovascular Diseases
- Cell Therapies
- Monoclonal Antibodies
- Small Molecule
- Vice President, Drug Safety
- Executive Director, Global Head of Pharmacovigilance
- Mid-Atlantic Area
- Open to remote, in-office, and travel
- Kyowa Kirin
- 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).