Associate Director, Signal Detection Scientist

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Product Safety

Pharmacovigilance

Scientific/Technology

Horsham, Pennsylvania, United States of America;
Raritan, New Jersey, United States of America;
Titusville, New Jersey, United States of America

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 Vigi Base, and EMA Eudra Vigilance databases. Support exploration of new signal detection methodologies, tools, and data sources to further the science of safety surveillance.

• 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.

• Minimum of a Bachelor’s degree, preferably in a healthcare‑related discipline. Advanced degree (Master’s, BSN, PharmD) preferred.
• Minimum of 3 years of…