Associate Director, Signal Detection and Surveillance
6 days ago
At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
Key Responsibilities
• Identify and assess new safety signals and trends by conducting systematic reviews of aggregate data with a focus on spontaneous adverse event reports. This includes signal detection activities in safety platforms.
• Demonstrates knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance.
• Provides medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc.
• Serve as an expert for internal signal-tracking tool and continues to build functionality to in-house tools.
• Responsible for the data mining process, implementation of data mining and coordinating data mining runs and tracking outputs and signals.
• Creates signal management strategy for department through process improvement and lessons learned.
• Prepare reviews of topics and summary analysis reports of safety data, with minimal guidance. Provide recommendations for further signal evaluation in a timely manner.
• Work with key business partners in developing and implementing product-specific surveillance plans.
• Participate as member of the matrix teams to address product specific safety issues, assist in the development of signal evaluation strategies, and participate in signal evaluation.
• Communicate findings from routine and ad-hoc signal detection and assessment activities.
• Responsible to develop and implement programmatic surveillance of adverse event reports for potential safety and product quality issues.
• Assist in the evaluation of novel, computer-assisted tools and methodologies for analysis of safety data, including piloting new data source and methodologies.
• Contributes to submission related documents (labeling documents, REMS/RMPs, etc)
• Trains staff on signal detection activities and signal management processes
• Maintain a state of inspection readiness
Requirements
• Advanced Healthcare-related Degree (e.g., RN, PA, PharmD) with
• Minimum requirement: 5+ years of industry experience in drug safety or related area required.
• Understanding of global health authority regulations and guidances surrounding the processing, reporting and evaluation of adverse events is required.
• Understanding in single case processing, aggregate data review and evaluation of drug safety issues, adverse event dictionaries, literature publications, core labeling, and Periodic Safety Review preparation is required.
• Ability to present complex data in a concise and understandable scientific manner is required.
• Familiarity with applied epidemiologic principles of case series evaluation and understanding of computer-assisted methodologies for safety data analysis is preferred.
• Knowledge in public health surveillance and tools (relevant work experience or Masters Public Health or equivalent) is preferred.
• Knowledge of statistics, or system analytics, information systems engineering, or machine learning is preferred.
• Ability to process data with Excel and SAS JMP is preferred.
• Ability to lead projects utilizing analytical approach is preferred.
• Ability to thrive in a global, matrix environment.
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