Signal Detection Physician - 2406186596W

Description

Johnson & Johnson is recruiting for a Signal Detection Physician to be located in Lisbon, Portugal.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

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 (https://www.jnj.com/credo/) .

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The objective of this position is to provide medical expertise in the assessment of safety data from a variety of postmarketing sources for signal detection 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 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 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).

This position will also 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.

The role also supports exploration of new signal detection methodologies, tools and data sources to further the science of safety surveillance.

Principal responsibilities:

• Identify and assess new safety signals and trends by conducting systematic reviews of aggregate safety data, e.g. spontaneous and noninterventional adverse event reports.

o 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.

o 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.

o 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.

o Assist in the development of signal evaluation strategies, including providing guidance on data sources and methods of analysis.

o 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.

o 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.

o This includes the development of educational materials and provision of training of stakeholders and new personnel in the SMG.

o 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.

Qualifications

Education and Experience:

• A Physician (MD or equivalent) is required.

• A Board Certification (if US) is preferred.

• Medical specialization is preferred.

• A minimum of 3 years of experience in industry, academia or patient care settings is required.

• A minimum of 1 year in clinical practice after postgraduate training program is preferred.

• Direct experience in pharmacovigilance is preferred. Limited PV experience will be considered on a case-by-case basis in the context of the applicant’s overall application.

• Fluent in written and spoken English required.

• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers required.

• Must be able to work independently with minimum supervision to meet tight deadlines.

• 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.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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 .

#MSLisbon

Primary Location Europe/Middle East/Africa-Portugal-Lisbon-Lisbon

Organization Janssen-Cilag Farmaceutica, Lda. (7290)

Job Function Product Safety Risk Management MD

Req ID: 2406186596W