Director, Signal Detection Scientist (Pharmacovigilance)

Location: High Wycombe, Buckinghamshire, United Kingdom; up to 10% domestic and international travel required

Company

Johnson & Johnson MedTech develops healthcare solutions and innovative medicines focused on preventing, treating, and curing complex diseases.

What you will do

• Lead signal detection and validation for complex and innovative pharmaceutical products using aggregate safety data and company safety platforms.
• Develop and implement product-specific post-marketing surveillance plans and programmatic monitoring of adverse event reports.
• Prepare safety reviews and analysis reports, communicate findings to Medical Safety Officers and Safety Management Teams, and recommend further evaluation.
• Guide signal evaluation strategies, data-source selection, and analysis methods, including mining FDA AEMS, WHO VigiBase, EMA EudraVigilance, and the Global Safety Database.
• Evaluate and pilot novel computer-assisted tools, methodologies, and data sources for safety surveillance.
• Provide technical leadership, stakeholder training, mentoring, and support for cross-functional and regulatory activities.

Requirements

• Advanced healthcare-related degree, such as RN or PharmD, with at least 9 years of industry experience in pharmacovigilance, drug safety, or a related field.
• At least 3 years of full-time experience in pharmacovigilance signal detection and at least 1 year of clinical or patient-care experience.
• In-depth knowledge of signal detection systems and methodologies, global health authority regulations, adverse event processing, and safety evaluation.
• Experience with single-case medical assessment, aggregate adverse event reviews, drug safety issues, adverse event dictionaries, core labeling, and Periodic Safety Review preparation.
• Ability to present complex scientific data clearly, lead projects, influence decisions, collaborate in a global matrix environment, and manage critical workloads.
• Strong communication, organization, analytical, and Excel data-manipulation skills.

Nice to have

• Experience with SAS JMP or related platforms.
• Applied epidemiology experience, public health surveillance knowledge, or a Master of Public Health.
• Knowledge of statistics, systems analytics, information systems engineering, or machine learning.

Culture & Benefits

• Inclusive work environment centered on individual dignity, diversity, and equal opportunity.
• Cross-functional collaboration with physicians, scientists, safety partners, and global teams.
• Opportunities to contribute to safety science, surveillance innovation, and stakeholder training.
• Travel of up to 10% across domestic and international locations.