Johnson & Johnson
Associate Director, Signal Detection Scientist
Johnson & Johnson, Titusville, New Jersey, us, 08560
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.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
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, e.g., claims and electronic medical records.
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.
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 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.
QualificationsEducation:
Bachelor’s Degree required
Advanced Healthcare-related Degree 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.
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
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.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on September 25, 2024.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
#J-18808-Ljbffr
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
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, e.g., claims and electronic medical records.
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.
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 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.
QualificationsEducation:
Bachelor’s Degree required
Advanced Healthcare-related Degree 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.
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
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.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on September 25, 2024.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
#J-18808-Ljbffr