Senior Specialist I, Patient Safety & Pharmacovigilance (Clinical Trial Safety Operations)

Role: Support Patient Safety and Pharmacovigilance (PSPV) Safety Operations by ensuring quality, compliance, and timely safety reporting for clinical trials, investigator studies, and expanded access programs. Responsibilities: conduct safety report reviews for accuracy and regulatory adherence, reconcile safety data, generate follow-up queries, review safety submissions, oversee vendor monitoring, and contribute to SOPs, training, process improvements, and audits. Requirements: Bachelor's in healthcare or life sciences (RN, BSN, PharmD preferred), 3+ years in PSPV operations within pharma/biotech or 5+ years clinical-study experience (CRC, CRA, research nurse). Knowledge of FDA, EU, ICH safety guidelines, and systems like Argus or Medidata RAVE. Skills: strong communication, collaboration, multi-project management, adaptability in a fast-paced environment. Preferred: experience in oncology clinical trials. Work setup: headquarters-based in the US, with up to 10% travel.