SENIOR DIRECTOR, SIGNAL DETECTION AND ANALYTICS-7463140618
Description
Janssen Research & Development (JRD), a member of the Johnson & Johnson Family of Companies, is recruiting for a Senior Director, Signal Detection and Analytics located in Horsham, PA, Spring House, PA, Titusville, NJ, or Raritan, NJ.
JRD develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, oncology, infectious disease, diabetes, metabolic disorders, and immunologic disorders.
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The Senior Director, Signal Detection and Analytics will lead a group of physicians who are responsible for the evaluation and reporting of adverse event data for JnJ products under GMS responsibility according to international regulation and company SOPs as well as aggregate signal detection (SD), implementing departmental surveillance strategies in proactive and systematic detection and evaluation of new safety signals and emerging trends from postmarketing safety data. Additionally, this functional line leader will be responsible for leading innovation in processes, methods, and science for single case review. The incumbent is responsible for assuring that the workload is appropriately assigned and that output meets quality standards. The incumbent is also responsible for leading collaborative interaction with the Global Medical Safety Operations (GMSO) and the Medical Safety Assessment Groups; the execution of any specialized surveillance activities including but not limited to Watch Lists, PSUR, PADER, aggregate review of safety data, product quality complaints, etc. In addition, lead a group of safety data analysts and safety data programmers who are responsible for providing safety data reports and programming from the Global Medical Safety database to end-users.
The Senior Director, Signal Detection and Analytics will direct, supervise and provide leadership to the Single Case Safety Analysis, Aggregate Signal Detection and Methods & Analysis (SCSA/ASD/M&A) Team for JnJ products under GMS responsibility. S/he will assign workload as appropriate to assure compliance with timelines and completion of projects, oversee technical quality of outputs for preparation of individual case safety reports and aggregate safety analyses (e.g., Watch Lists, PSUR, PADER, aggregate review of safety data, product quality complaints, real time signal detection), and also ensure active participation of Team members in Safety Management Teams (SMT) as well as vendor oversight aligned within the governance framework.
The Senior Director, Signal Detection and Analytics will lead collaboration within both GMSO and more broadly GMO, Janssen R&D academic centers and regulatory authorities. The collaboration within GMSO must focus on ensuring that Signal Detection and Analysis Science members participate in cross functional therapeutic area teams as subject matter experts. As regards the broader collaboration within GMO, the SCSA/ASD/M&A members must coordinate closely with GMSO to guarantee an optimal process for flow of adverse event data and also must function as medical subject matter experts on safety issues in the Safety Management Teams and lead the GMS Product Teams. In addition physicians and scientists must serve as SMEs for signal detection activities.
The Senior Director, Signal Detection and Analytics will lead process, tools, technology and scientific innovations, including computational signal detection algorithms and statistical approaches for SCSA/ASD/M&A work to process, and evaluate safety from single and aggregate reviews of data. S/he will develop a strong understanding of pharmacovigilance regulations especially regarding individual and aggregate case safety analysis and design and implementation of statistical approaches to signal detection. S/he will evaluate and identify training needs in order to assure compliance with global pharmacovigilance regulations and corporate SOPs and policies and maintain scientific and medical expertise in areas of responsibility.
Qualifications
A Medical degree with over 5 years of industry experience in drug safety or related area is required. Single case processing experience and drug development processes experience is desired. Aggregate signal detection and reporting experience is required. An in-depth understanding of global health authority regulations and guidances surrounding the processing, reporting and evaluation of adverse events is mandatory. Knowledge in the use of statistical techniques used in single case and signal detection as well as experience applying these technologies is required. Experience in understanding medical aspects of pharmacovigilance, MedDRA coding, and evaluation and management of safety issues including the preparation of aggregate safety reports such as Periodic Safety Update Reports, health authority safety reports, etc. is an advantage. Medical degree from recognized institution with 2-5 years of clinically relevant experience is preferred. Board certification in a recognized primary care specialty (particularly internal medicine or subspecialty, pediatrics, preventive medicine or family medicine) or equivalent is strongly suggested. This position is located in Horsham, PA, Spring House, PA, Titusville, NJ, or Raritan, NJ. There will be up to 20% domestic and international travel.
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Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Pharmacovigilance
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