Pharmacovigilance Physician (Post Market Signal Detection) - 2406160295W

　　Description

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

　　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 (https://www.jnj.com/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 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.

　　Qualifications

　　Required:

　　MD (or equivalent) from a recognized medical institution.

　　A minimum of 3 years of clinical experience in industry, academia or patient care setting

　　A minimum of 1 year in clinical practice after postgraduate training program

　　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.

　　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 Research & Development, LLC (6084)

　　Job Function Pharmacovigilance

　　Req ID: 2406160295W