Job Function: Product Safety
Job Sub Function: Pharmacovigilance
Job Category:Scientific/Technology
All Job Posting Locations:Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description: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.
The Associate Director, Signal Detection Scientist will lead the implementation of the Signal Management Group 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.
The Associate Director will develop and implement product-specific surveillance plans, perform post-marketing signal detection activities, including signal validation, and participate in communication of emerging signals in forums, such as the Product Team Meetings and Safety Management Team Meetings. This individual will also participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis. May perform activities supporting signal evaluation, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases. Support exploration of new signal detection methodologies, tools, and data sources to further the science of safety surveillance.
Principal 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.
- 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 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.
- Understanding of computer-assisted methodologies for safety data analysis is preferred.
- Knowledge of public health surveillance and tools 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.
- Must have excellent verbal and written communication skills.
- Must have strong organization and analytical skills.
- The ability to lead projects is required.
- The ability to present complex data in a concise and understandable scientific manner is required.
- The ability to collaborate with all levels and influence decision-making in a global, matrix environment is required.
- This position will require up to 10% domestic and international travel.
Required Skills:Preferred Skills:The anticipated base pay range for this position is :$137,000.00 - $235,750.00
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.
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 calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
