SIGNAL DETECTION PHYSICIAN

Job description

Job Description

Requisition ID: 4325190117

Janssen Research & Development, LLC, a member of the J&J Family of Companies, is recruiting for a Signal Management Physician located in Horsham, PA.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine

The Signal Management Physician will:

·  Provide medical expertise in the assessment of safety data from a variety of postmarketing sources as part of the overall surveillance program for Janssen products. This position leads the implementation of the Signal Management Group (SMG) surveillance strategies for proactive and systematic detection and the evaluation of new safety signals and emerging trends from post-marketing safety data. These activities include the development as well as use of novel, computer-assisted tools and statistical methodologies for signal detection in the internal company safety data, international regulatory safety databases, and other data sources, e.g. claims and electronic medical records
·  The Signal Management Physician also provides oversight and medical guidance to the scientist in the group in the completion of surveillance activities, analysis of safety data, and conclusions derived from these analyses
·  Develops and implements product-specific surveillance plans, performs signal detection activities, including signal validation, and participates in communication of emerging signals to the Medical Safety Officers and in forums such as the Safety Management Teams (SMTs)
·  Participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis and may include performing 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
·  Identify and assess new safety signals and trends by conducting systematic reviews of aggregate safety data, e.g. spontaneous and noninterventional adverse event reports
·  Perform signal detection activities in the Company safety platforms for products of responsibility, including SMART, routine and ad hoc data mining in Empirica Signal, and signal entry into Empirica Topics
·  Perform validation of safety signals identified in reviews. Prepare reviews of topics and summary analysis reports of safety data. Communicate findings to Medical Safety Officers and the SMTs. Provide recommendations for further evaluation
·  Perform aggregate surveillance of adverse event reports for potential product quality issues.
·  Work with key customers and business partners (MSOs, PVERs, and SSPs) 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, including providing guidance on data sources and methods of analysis
·  Participate in signal evaluation, including case definition development, review of the signal tracking system, ad hoc data mining in FAERS, Vigibase, and SCEPTRE
·  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
·  This includes the development of educational materials and provision of training of stakeholders and new personnel in the SMG
·  Provide oversight of SMG scientist and others (fellows)
·  Assist in the evaluation of novel, computer-assisted tools and methodologies for analysis of safety data, including piloting new data sources and methodologies

Desired profile

Qualifications

Qualifications:

·  Medical degree from a recognized institution with over 3-5 years of industry experience in drug safety or related area
·  Familiarity with applied epidemiologic principles of case series evaluation and understanding of computer-assisted methodologies for safety data analysis is preferred. Understanding of global health authority regulations and guidances surrounding the processing, reporting and evaluation of adverse events is required. Understanding in single case processing, aggregate data review and evaluation of drug safety issues, adverse event dictionaries, core labeling, and Periodic Safety Review preparation is required
·  Knowledge in public health surveillance and tools (relevant work experience or MPH or equivalent) preferred
·  Knowledge of statistics, or system analytics, information systems engineering, or machine learning is preferred
·  Ability to present complex data in a concise and understandable scientific manner is required. Ability to manipulate data in platforms such as Excel and SAS JMP is preferred
·  Ability to lead projects required, analytical approach preferred
·  Ability to thrive in a global, matrix environment. Ability to manage high workload and critical issues

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-Pennsylvania-Horsham-800/850 Ridgeview Drive
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Drug & Product Safety Science
Requisition ID
4325190117