Manager - Global Pharmacovigilance

Role: Pharmacovigilance Specialist responsible for safety evaluation and management of Pharming's products in development and post-authorization. Responsibilities include case processing, signal detection, data retrieval, regulatory safety queries, and ensuring compliance with global drug safety regulations. Key tasks involve AE data collection, assessment, database entry, follow-up communication, expedited report submission to authorities (FDA, EMA), safety data reconciliation, and development of safety reports. Requirements: BS in life sciences, pharmacy, or nursing, with at least three years of industry pharmacovigilance experience; extensive knowledge of case processing, drug safety evaluation, and safety databases (ARGUS preferred); thorough understanding of GVP, GCP, and ICH guidelines. Preferred qualifications include a Master’s or PharmD. High-value specifics: focus on rare disease therapies, with responsibilities spanning both clinical and post-market safety, emphasizing compliance, regulatory reporting, and safety data analysis. The role involves collaboration with internal teams and external partners, supporting safety-related proposals and audits. Work setup is hybrid (at least two days onsite in Warren, NJ). The position offers a salary range of $105,000 to $135,000, along with comprehensive benefits and a focus on global pharmacovigilance standards.