Signal Management Scientist, Associate Director (1 Of 2 Positions)

Johnson & Johnson Raritan , NJ 08869

Posted 3 months ago

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for Signal Management Scientist, Associate Director (2 positions). This position will be located at a J&J site in either: Horsham, PA; Titusville, NJ; Raritan, NJ, J&J US site locations or J&J Global Site locations in Europe may be considered, or remotely located may be considered.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

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 for complex pharmaceutical products (e.g., large innovative programs, new therapeutic areas, or complex business partner relationships). These activities include the evaluation, piloting, as well as 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.

This position 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 Meetings and Safety Management Team Meetings. This position will also participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis. The position may also perform activities supporting signal evaluation, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases.

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, 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 (MSOs, Safety Scientists, GMSO Physicians 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

  • Advanced Healthcare-related Degree (e.g., RN, PharmD) with at least 3 or more years of industry experience in drug safety or related area required.

  • 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.

  • Ability to present complex data in a concise and understandable scientific manner is required.

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

  • Knowledge in public health surveillance and tools (relevant work experience or Masters Public Health or equivalent) is preferred.

  • Knowledge of statistics, or system analytics, information systems engineering, or machine learning is preferred.

  • 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.

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The base pay range for this position is $122,000 to $183,000 (USD).

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

Information on benefits can be viewed by following this link: https://www.careers.jnj.com/employee-benefits

Primary Location

United States-Pennsylvania-Horsham-800/850 Ridgeview Drive

Other Locations

Europe/Middle East/Africa-Switzerland, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105960673W

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Signal Management Scientist, Associate Director (1 Of 2 Positions)

Johnson & Johnson