Associate Director, Signal Detection Scientist

About the role

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.
• 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.
• An advanced degree (Master’s, BSN, PharmD) is 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.
• 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.

Required Skills

• Must have excellent verbal and written communication skills.
• Must have 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.
• Up to 10% domestic and international travel may be required.

Additional Description

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. Benefits Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits