Associate Director, Signal Detection Scientist

About the role

Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Signal Detection Scientist. This position is a hybrid role and will be located in Titusville, NJ; Raritan, NJ; or Horsham, PA.

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, including our Company signal detection system and routine and ad hoc data mining in Empirica Signal.
• 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.
• Aid in the development and implementation of programmatic surveillance of adverse event reports for potential safety and product quality issues.
• Aid in the evaluation of novel, computer-assisted tools, and methodologies for analysis of safety data, including piloting new data sources and methodologies.

Qualifications

• A minimum of a Bachelor’s degree is required, preferably in a healthcare-related discipline. Advanced degree (Master’s, BSN, PharmD) preferred.
• A minimum of 3 years of industry experience in pharmacovigilance/drug safety or related area is required.
• A minimum of 1 year of clinical/patient-care experience is highly preferred.
• Understanding of global health authority regulations and guidance surrounding the processing, reporting and evaluation of adverse events is required.
• Understanding of the following is required: single case medical assessment; post-marketing aggregate adverse event data reviews; evaluations of drug safety issues; adverse event dictionaries; core labeling; Periodic Safety Review preparation.
• Familiarity with applied epidemiologic principles of case series evaluation is preferred.
• Knowledge of computer-assisted methodologies for safety data analysis is preferred.
• Knowledge of statistics, system analytics, information systems engineering, or machine learning is preferred.
• Experience manipulating data in MS Excel is required.
• Experience with SAS JMP, or related platforms is preferred.

Required Skills

• Excellent verbal and written communication skills.
• Strong organization and analytical skills.
• The ability to lead projects.
• The ability to present complex data in a concise and understandable scientific manner.
• The ability to collaborate with all levels and influence decision-making in a global, matrix environment.

Additional Description

This position will require up to 10% domestic and international travel.

Benefits

• For Pay Transparency Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits.