Associate Director, Signal Detection Scientist

Johnson & Johnson•Titusville, NJ

43d

About The Position

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. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for an Associate Director, Signal Detection Scientist located in Titusville, NJ or Raritan, NJ or Horsham, PA . The objective of this position is to 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. 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. This position will also participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis. The position may also perform activities supporting signal evaluation, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases. The role also supports exploration of new signal detection methodologies, tools, and data sources to further the science of safety surveillance.

Requirements

Bachelor’s Degree required
Advanced Healthcare-related Degree (e.g., RN, BSN, PharmD) with 3+ years industry experience in pharmacovigilance / drug safety or related area and 1+ year of clinical/patient-care experience highly preferred
Understanding of global health authority regulations and guidance surrounding the processing, reporting and evaluation of adverse events
Understanding 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

Nice To Haves

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 of 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

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 PV 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 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.

Benefits

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