Senior Specialist I, Postmarketing Patient Safety and Pharmacovigilance Operations

Role: Support drug safety and pharmacovigilance activities in a post-marketing setting, focusing on case management, vendor oversight, and compliance. Responsibilities: oversee safety service providers, ensure adverse event report collection and reporting compliance, perform quality reviews, develop SOPs and training, support process improvements, and participate in audits and safety projects. Requirements: Bachelor's in healthcare or life sciences (RN, BSN, PharmD preferred), 3+ years in global patient safety/pharmacovigilance, experience with post-marketing safety operations, knowledge of FDA, EU, ICH guidelines, and safety systems like Argus, MedDRA, WHO Drug coding. HighValue: post-market safety, pharmacovigilance, adverse event processing, global regulatory compliance, safety systems proficiency. WorkSetup: full-time US-based, remote; no travel specified.