Associate Director Global Patient Safety
$157,200–$256,600 year
HybridCambridge, Massachusetts, United States or Tarrytown, New York, United States
Job Summary
Lead vendor oversight for end-to-end Individual Case Safety Report receipt, processing, distribution, and submission while establishing tiered quality review frameworks aligned to case complexity and risk. Own ICSR quality standards covering narrative accuracy, case validity, and source document reconciliation, then monitor submission timelines and vendor SLAs to maintain inspection readiness. Conduct root cause analysis and manage corrective and preventive actions through closure and effectiveness checks. Evaluate AI-enabled tools for data ingestion, workflow automation, and metrics. Mentor staff and communicate clearly with senior management and partners across global development and commercial programs.
Required Qualifications
- Pharmacy, nursing, or equivalent degree
- Advanced degree
- 10 years of Pharmacovigilance, Drug Safety, or PV Quality experience in pharma or biotech
- Well-informed on FDA, EU, and ICH guidelines governing pharmacovigilance for clinical trial and post-marketing environments
- Experience managing teams on complex, cross-functional projects
- Proven ability to deliver organisational projects through individual contributors or other managers
- Strong communication and partner management skills, with ability to resolve and escalate complex issues
- Onsite position to be based in one of our US locations or in Uxbridge, UK (hybrid)
Desired Qualifications
- Advanced degree preferred
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