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. With smarter, less invasive treatments and solutions backed by our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today, delivering breakthroughs of tomorrow and profoundly impacting health for more at all.
Job Function: Product Safety
Job Sub Function: Pharmacovigilance
Job Category: Scientific / Technology
All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom
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.
We are searching for the best talent for the Associate Director Signal Detection Scientist located in High Wycombe, UK.
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 a 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 sources and methodologies.
Qualifications – Education
* Bachelor’s Degree required.
* Advanced Healthcare‑related Degree (e.g., RN, BSN, PharmD) with 3 years industry experience in drug safety or a 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 of 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 Master’s in Public Health or equivalent).
* Knowledge of statistics or system analytics, information systems engineering, or machine learning.
Key Skills
* Laboratory Experience
* ELISA
* Immunoassays
* Transfection
* Mammalian Cell Culture
* Suspension Experience
* Biochemistry
* Assays
* cGMP
* Cell Culture
* Molecular Biology
* Flow Cytometry
Employment Type: Full‑Time
Experience: N/A (Director level)
Vacancy: 1
#J-18808-Ljbffr