Director, Signal Detection Scientist

Role: Lead signal detection activities within pharmacovigilance for complex, innovative pharmaceutical products, overseeing proactive safety monitoring and evaluation of emerging signals from post-marketing data sources. Responsibilities: develop and implement surveillance strategies, perform signal validation, prepare analytical reviews, and communicate findings to safety and cross-functional teams. Contribute to the development of methodologies for signal detection, including data mining from global safety databases like FDA AEMS, VigiBase, and EMA EudraVigilance; evaluate new tools and data sources; mentor team members; and support regulatory interactions. Requirements: advanced healthcare degree (e.g., RN, PharmD) with at least 9 years in industry pharmacovigilance, including 3+ years in signal detection; clinical/patient care experience; deep understanding of signal detection systems, global safety regulations, and adverse event assessment; proficiency in data manipulation (e.g., Excel); excellent communication skills. Preferred: experience with SAS JMP, epidemiologic principles, public health surveillance, and knowledge of machine learning or data analytics. HighValue: healthcare/pharmacovigilance, post-marketing safety, complex biologics or small molecule therapies, global safety databases, signal detection methodologies, cross-functional collaboration, potential international travel. Location: multiple US sites; up to 10% travel.