Associate Director, Signal Detection Scientist

High Wycombe - UK

Monthly Salary: Not Disclosed

Posted on: 8 hours ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Product Safety

Job Sub Function:

Pharmacovigilance

Job Category:

Scientific/Technology

All Job Posting Locations:

High Wycombe Buckinghamshire United Kingdom

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for Associate Director Signal Detection Scientist located in High Wycombe UK.

The objective of this position is to lead the implementation of the Signal Management Group aggregate 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 development evaluation piloting and 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. The role also supports exploration of new signal detection methodologies tools and data sources to further the science of safety surveillance.

Primary 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 our Company signal detection system and 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 (Medical Safety Officers Safety Scientists and other Safety Physicians) 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:

Education:

Bachelors Degree required

Advanced Healthcare-related Degree (e.g. RN BSN PharmD) with 3 years industry experience in drug safety or related area and 1 year of clinical/patient-care experience highly preferred

Required:

Understanding of global health authority regulations and guidances surrounding the processing reporting and evaluation of adverse events
Understanding in single case medical assessment post-marketing aggregate adverse event data reviews evaluations of drug safety issues adverse event dictionaries core labeling and Periodic Safety Review preparation
Ability to lead projects
Skillful in presenting complex data in a concise and understandable scientific manner
Ability to thrive in a global matrix environment - able to handle high workload and critical issues.

Up to 10% travel Domestic & International

Preferred:

Ability to manipulate data in platforms such as Excel and SAS JMP
Familiarity with applied epidemiologic principles of case series evaluation and understanding of computer-assisted methodologies for safety data analysis
Knowledge in public health surveillance and tools (relevant work experience or Masters Public Health or equivalent)
Knowledge of statistics or system analytics information systems engineering or machine learning

Required Skills:

Preferred Skills:

Required Experience:

Director