Specialist I, Patient Safety and Pharmacovigilance Operations

Role: Support Patient Safety and Pharmacovigilance (PSPV) Safety Operations in postmarketing and clinical trial settings. Objectives: Manage safety intake channels, ensure timely review, documentation, and escalation of safety information. Responsibilities: monitor and triage safety communications from shared mailboxes, identify potential adverse events and safety signals, route and archive reports, support training and audit activities, and assist with regulatory inspections. Requirements: Bachelor's degree in healthcare or life sciences (RN, BSN, PharmD), 1+ years in healthcare, pharma, or biotech; familiarity with pharmacovigilance regulations and safety reporting; strong communication skills; ability to collaborate in a fast-paced environment. Preferred: knowledge of global PV regulations, experience with safety systems, and flexibility for travel (up to 10%) and in-office presence (>3 days/week). HighValue: PV safety operations, safety data intake, regulatory compliance, postmarketing and clinical trial safety, cross-functional collaboration, biotech/pharma setting.