J&J Family of Companies
Associate Director, Signal Detection Scientist
J&J Family of Companies, Helena, Montana, us, 59604
J&J Family of Companies Associate Director, Signal Detection Scientist Helena, Montana Apply Now
Associate Director, Signal Detection Scientist - 2406212640WDescriptionJohnson and Johnson is currently seeking an
Associate Director, Signal Detection Scientist
located in Titusville, NJ; Raritan, NJ; Horsham, PA; OR High Wycombe, UK. Remote work options in the US or UK may be considered on a case-by-case basis and if approved by the company.The objective of this position is to lead the implementation of the Signal Management Group’s aggregate surveillance strategies for proactive and systematic detection and evaluation of new safety signals and emerging trends from post-marketing safety data for complex pharmaceutical products. These activities include the development, 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.This position develops and implements product-specific surveillance plans, performs post-marketing signal detection activities, including signal validation, and participates in communication of emerging signals in forums, such as the Product Team Meetings and Safety Management Team Meetings. The position may also perform activities supporting signal evaluation, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases.Primary 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.Prepare reviews of topics and summary analysis reports of safety data, with minimal guidance.Provide recommendations for further signal evaluation.Work with key customers and 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.Assist in the development and implementation of 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.QualificationsEducation:Bachelor’s Degree required. Advanced Healthcare-related Degree (e.g., RN, BSN, PharmD) with 3 years industry experience in drug safety or related area and 1 year of clinical/patient-care experience highly preferred.Required:Understanding of global health authority regulations and guidance surrounding the processing, reporting and evaluation of adverse events.Understanding in single case medical assessment, post-marketing aggregate adverse event data reviews, evaluations of drug safety issues.Ability to lead projects.Skillful in presenting complex data in a concise and understandable scientific manner.Ability to thrive in a global, matrix environment.Up to 10% travel – Domestic & International.Preferred:Ability to manipulate data in platforms such as Excel and SAS JMP.Familiarity with applied epidemiologic principles of case series evaluation.Knowledge in public health surveillance and tools.Knowledge of statistics, or system analytics, information systems engineering, or machine learning.The anticipated base pay range for this position in the US is $135,000 to $232,300. The anticipated base pay range for this position in San Francisco Bay Area is $166,000 to $267,145.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. Employees and/or eligible dependents may be eligible to participate in various Company-sponsored employee benefit programs.This job posting is anticipated to close on September 25, 2024. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.Primary Location
NA-US-New Jersey-TitusvilleOther Locations
Europe/Middle East/Africa-United Kingdom, NA-United States
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Associate Director, Signal Detection Scientist - 2406212640WDescriptionJohnson and Johnson is currently seeking an
Associate Director, Signal Detection Scientist
located in Titusville, NJ; Raritan, NJ; Horsham, PA; OR High Wycombe, UK. Remote work options in the US or UK may be considered on a case-by-case basis and if approved by the company.The objective of this position is to lead the implementation of the Signal Management Group’s aggregate surveillance strategies for proactive and systematic detection and evaluation of new safety signals and emerging trends from post-marketing safety data for complex pharmaceutical products. These activities include the development, 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.This position develops and implements product-specific surveillance plans, performs post-marketing signal detection activities, including signal validation, and participates in communication of emerging signals in forums, such as the Product Team Meetings and Safety Management Team Meetings. The position may also perform activities supporting signal evaluation, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases.Primary 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.Prepare reviews of topics and summary analysis reports of safety data, with minimal guidance.Provide recommendations for further signal evaluation.Work with key customers and 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.Assist in the development and implementation of 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.QualificationsEducation:Bachelor’s Degree required. Advanced Healthcare-related Degree (e.g., RN, BSN, PharmD) with 3 years industry experience in drug safety or related area and 1 year of clinical/patient-care experience highly preferred.Required:Understanding of global health authority regulations and guidance surrounding the processing, reporting and evaluation of adverse events.Understanding in single case medical assessment, post-marketing aggregate adverse event data reviews, evaluations of drug safety issues.Ability to lead projects.Skillful in presenting complex data in a concise and understandable scientific manner.Ability to thrive in a global, matrix environment.Up to 10% travel – Domestic & International.Preferred:Ability to manipulate data in platforms such as Excel and SAS JMP.Familiarity with applied epidemiologic principles of case series evaluation.Knowledge in public health surveillance and tools.Knowledge of statistics, or system analytics, information systems engineering, or machine learning.The anticipated base pay range for this position in the US is $135,000 to $232,300. The anticipated base pay range for this position in San Francisco Bay Area is $166,000 to $267,145.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. Employees and/or eligible dependents may be eligible to participate in various Company-sponsored employee benefit programs.This job posting is anticipated to close on September 25, 2024. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.Primary Location
NA-US-New Jersey-TitusvilleOther Locations
Europe/Middle East/Africa-United Kingdom, NA-United States
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