Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Signal Management Physician. This position will be based in Horsham, PA (strongly preferred), Titusville, NJ, Raritan NJ, Springhouse, PA, or Morris Plains, NJ.  Up to 10% travel is required.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.  

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.  

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The objective of this position is to implement Signal Management Group (SMG) surveillance strategies for proactive and systematic detection and evaluation of new safety signals and emerging trends from post-marketing safety data. These activities include the evaluation, piloting, as well as use of novel, computer-assisted tools and methodologies for analysis of internal company safety data, international regulatory safety databases, and other data sources, e.g. claims and electronic medical records and social media.

This position, in partnership with other SMG physicians and scientists, 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 Meeting, Signal Management Teams, and monthly Product Quality Meetings. This position will also participate in the development of strategies for signal evaluation, and may include performing activities supporting signal evaluation, such as case definition development (including database query criteria), review of the signal tracking system, ad hoc data mining FAERS, Vigibase, and SCEPTRE, and narrative text mining.

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 SMART, lot alerts system, routine and ad hoc data mining in Empirica Signal, and signal entry to Empirica Topics.
• Prepare reviews of topics and summary analysis reports of safety data, in consultation with the SMG physicians.
• Provide recommendations for further evaluation.
• 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, 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 source and methodologies.

Qualifications

• A Medical degree is required
• A minimum of 2 years of industry experience in drug safety or related area is required 
• Board certification is required, preferably in a recognized primary care specialty (internal medicine or subspecialty, pediatrics, preventive medicine or Family Medicine).
• Good understanding of the strengths and limitations of company and regulatory safety databases is preferred
• Familiarity with applied epidemiologic principles of case series evaluation, and computer-assisted methodologies for safety data analysis  is preferred
• An in-depth understanding of global health authority regulations and guidances surrounding the processing, reporting and evaluation of adverse events is required
• Good understanding in single case processing, aggregate data review and evaluation of drug safety issues, core labeling, preparation and review of Periodic Safety Review are required. 
• Knowledge of multiple adverse event dictionaries is required
• Knowledge in public health surveillance and tools (relevant work experience or MPH or equivalent) is preferred
• Ability to thrive in a global, matrix environment
• Ability to manage high workload and critical issues

Primary Location
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-Morris Plains, North America-United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Drug & Product Safety Science