ZipRecruiter
Associate Director, GDS&PV Signal Detection & Risk Management Scientist
ZipRecruiter, Plainsboro, New Jersey, United States,
Job Description
At Genmab, we’re committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. We believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
As our Associate Director, you must effectively implement Signal Management Group surveillance strategies for proactive and systematic detection and evaluation of new safety signals and emerging trends from clinical and post-marketing safety data for complex pharmaceutical products (e.g., large innovative programs, new therapeutic areas, or complex business partner relationships).
These activities include the evaluation, piloting, and use of novel, computer-assisted tools and methodologies for signal detection and analysis of internal company safety data, international regulatory safety databases, and other data sources, e.g., claims and electronic medical records.
This position develops and implements product-specific surveillance plans, performs clinical and post-marketing signal detection activities, including signal validation, and participates in communication of emerging signals in forums. This position will also participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis. The position may also perform activities supporting signal evaluation, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases.
Key Responsibilities
Identify and assess (validate) 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.
Demonstrate 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.
Provide medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc.
Serve as an expert for internal signal-tracking tool and continue 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.
Create signal management strategy for the 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 a 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 sources and methodologies.
Contribute to submission related documents (labeling documents, REMS/RMPs, etc).
Train 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).
Minimum requirement: 5+ years of industry experience in drug safety or related area.
Understanding of global health authority regulations and guidances surrounding the processing, reporting, and evaluation of adverse events.
Understanding in single case processing, aggregate data review, and evaluation of drug safety issues.
Ability to present complex data in a concise and understandable scientific manner.
Familiarity with applied epidemiologic principles of case series evaluation and understanding of computer-assisted methodologies for safety data analysis.
Knowledge in public health surveillance and tools (relevant work experience or Masters Public Health or equivalent).
Knowledge of statistics, system analytics, information systems engineering, or machine learning.
Ability to process data with Excel and SAS JMP.
Ability to lead projects utilizing an analytical approach.
Ability to thrive in a global, matrix environment.
This role is hybrid and requires you to be in the Princeton, NJ office 3x per week.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative, and collaborative team has invented next-generation antibody technology platforms. Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies to help develop and deliver novel antibody therapies to patients.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website
https://www.genmab.com/privacy .
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year; if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
#J-18808-Ljbffr
At Genmab, we’re committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. We believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
As our Associate Director, you must effectively implement Signal Management Group surveillance strategies for proactive and systematic detection and evaluation of new safety signals and emerging trends from clinical and post-marketing safety data for complex pharmaceutical products (e.g., large innovative programs, new therapeutic areas, or complex business partner relationships).
These activities include the evaluation, piloting, and use of novel, computer-assisted tools and methodologies for signal detection and analysis of internal company safety data, international regulatory safety databases, and other data sources, e.g., claims and electronic medical records.
This position develops and implements product-specific surveillance plans, performs clinical and post-marketing signal detection activities, including signal validation, and participates in communication of emerging signals in forums. This position will also participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis. The position may also perform activities supporting signal evaluation, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases.
Key Responsibilities
Identify and assess (validate) 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.
Demonstrate 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.
Provide medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc.
Serve as an expert for internal signal-tracking tool and continue 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.
Create signal management strategy for the 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 a 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 sources and methodologies.
Contribute to submission related documents (labeling documents, REMS/RMPs, etc).
Train 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).
Minimum requirement: 5+ years of industry experience in drug safety or related area.
Understanding of global health authority regulations and guidances surrounding the processing, reporting, and evaluation of adverse events.
Understanding in single case processing, aggregate data review, and evaluation of drug safety issues.
Ability to present complex data in a concise and understandable scientific manner.
Familiarity with applied epidemiologic principles of case series evaluation and understanding of computer-assisted methodologies for safety data analysis.
Knowledge in public health surveillance and tools (relevant work experience or Masters Public Health or equivalent).
Knowledge of statistics, system analytics, information systems engineering, or machine learning.
Ability to process data with Excel and SAS JMP.
Ability to lead projects utilizing an analytical approach.
Ability to thrive in a global, matrix environment.
This role is hybrid and requires you to be in the Princeton, NJ office 3x per week.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative, and collaborative team has invented next-generation antibody technology platforms. Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies to help develop and deliver novel antibody therapies to patients.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website
https://www.genmab.com/privacy .
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year; if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
#J-18808-Ljbffr