Director, Signal Detection Physician

Johnson & Johnson is recruiting for a Director, Signal Detection Physician to be located Raritan, NJ; Titusville, NJ or Horsham, PA

At 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.

Johnson & Johnson discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more information.

We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo .

The objective of this position is to provide medical expertise in the assessment of safety data from a variety of post marketing sources for Signal Detection as part of the overall surveillance program for Johnson & Johnson products.

This position leads the implementation of the Global 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 Detection Physician also provides oversight and medical guidance to the Safety Management Team and team members in the group in the completion of surveillance activities, analysis of safety data, and conclusions derived from these analyses.

This position reports to the Senior Director, Signal Management Group Lead, which in turn reports to VP, Medical Analytics and Safety Surveillance (MASS).

RESPONSIBILITIES:

• 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.
• Supports 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, SASs, 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, VAERs, EudraViigilance, Vigibase, and Company safety database .
• 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 and mentoring of Assoc Dir SM Physicians, 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.

Required:

• MD (or equivalent) from a recognized medical institution.
• A minimum of 2 year in clinical practice after postgraduate training program
• A minimum of 3 years experience in drug safety or related area; pharmaceutical industry experience preferred
• Ability to present complex data in a concise and understandable scientific manner
• Ability to manipulate data in platforms such as Excel and SAS JMP
• Ability to lead projects required, analytical approach
• Ability to thrive in a global, matrix environment.
• Ability to manage high workload and critical issues.
• Ability to speak & write fluently in English

Preferred:

• Board Certified/Board Eligible preferred.
• Familiarity with applied epidemiologic principles of case series evaluation and understanding of computer-assisted methodologies for safety data analysis is preferred.
• 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 strongly preferred
• 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.

The anticipated base pay range for this position is $238,000 to $322,000.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .