J&J Family of Companies
Associate Director, Signal Detection Scientist
J&J Family of Companies, Baton Rouge, Louisiana, us, 70873
J&J Family of Companies Associate Director, Signal Detection Scientist Baton Rouge, Louisiana Apply NowAssociate Director, Signal Detection Scientist - 2406212640W
Description
Johnson 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 (e.g., large innovative programs, new therapeutic areas, or complex business partner relationships). 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, e.g., claims and electronic medical records.
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 (Medical Safety Officers, Safety Scientists, and other Safety Physicians) 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.
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, including piloting new data source and methodologies.
Qualifications
Education:
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, adverse event dictionaries, core labeling, and Periodic Safety Review preparation.
Ability to lead projects.
Skillful in presenting complex data in a concise and understandable scientific manner.
Ability to thrive in a global, matrix environment - able to handle high workload and critical issues.
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 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, or system analytics, information systems engineering, or machine learning.
This job posting is anticipated to close on September 25, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Description
Johnson 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 (e.g., large innovative programs, new therapeutic areas, or complex business partner relationships). 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, e.g., claims and electronic medical records.
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 (Medical Safety Officers, Safety Scientists, and other Safety Physicians) 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.
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, including piloting new data source and methodologies.
Qualifications
Education:
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, adverse event dictionaries, core labeling, and Periodic Safety Review preparation.
Ability to lead projects.
Skillful in presenting complex data in a concise and understandable scientific manner.
Ability to thrive in a global, matrix environment - able to handle high workload and critical issues.
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 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, or system analytics, information systems engineering, or machine learning.
This job posting is anticipated to close on September 25, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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