Director, Signal Detection Scientist

Role: Lead signal detection activities within pharmacovigilance for complex pharmaceutical products, focusing on proactive safety signal identification and evaluation from post-marketing data sources. Responsibilities: develop and implement surveillance strategies, perform signal validation, prepare safety data analyses, and communicate findings to safety teams and stakeholders. Lead cross-functional discussions on signal evaluation, guide data source selection and analysis methods, and support exploration of novel safety surveillance methodologies. Provide mentorship and contribute to training efforts. Requirements: advanced healthcare-related degree (e.g., RN, PharmD) with at least 9 years of industry experience in drug safety, including 3+ years in signal detection, and 1+ year of clinical/patient-care experience. Deep understanding of signal detection systems, global safety regulations, and data analysis tools (e.g., FDA AEMS, VigiBase). Preferred: experience with SAS JMP, epidemiologic principles, public health surveillance, and machine learning. High-value biopharma specifics include focus on post-marketing safety surveillance for large innovative or complex products, with responsibilities spanning signal detection, validation, and methodology development. Collaboration involves safety teams, medical officers, and global regulatory agencies. Location: multiple US sites; travel up to 10%. The role emphasizes scientific independence, leadership, and technological innovation in pharmacovigilance.