Associate Director, Signal Detection Scientist (Pharmacovigilance)

Location: Hybrid role based in Titusville, New Jersey; Raritan, New Jersey; or Horsham, Pennsylvania, United States. Up to 10% domestic and international travel is required.

Salary: $137,000–$235,750 per year

Company

Johnson & Johnson MedTech and Innovative Medicine develop healthcare solutions and medicines focused on preventing, treating, and curing complex diseases.

What you will do

• Lead aggregate surveillance strategies for proactive detection and evaluation of safety signals and emerging trends in post-marketing safety data.
• Develop and implement product-specific surveillance plans, including routine and ad hoc data mining in company safety systems and Empirica Signal.
• Conduct systematic reviews, validate signals, prepare safety-data reports, and recommend further evaluation.
• Analyze data from FDA FAERS, WHO VigiBase, EMA EudraVigilance, claims, electronic medical records, and other sources.
• Collaborate with Medical Safety Officers, Safety Scientists, Safety Physicians, and matrix teams on product-specific safety issues.
• Evaluate and pilot novel computer-assisted tools, methodologies, and data sources, and communicate findings to product and safety management forums.

Requirements

• Bachelor’s degree in a healthcare-related discipline; a Master’s degree, BSN, or PharmD is preferred.
• At least 3 years of industry experience in pharmacovigilance, drug safety, or a related area.
• Understanding of global health-authority regulations for adverse-event processing, reporting, and evaluation.
• Knowledge of single-case medical assessment, aggregate adverse-event reviews, drug-safety evaluations, adverse-event dictionaries, core labeling, and Periodic Safety Review preparation.
• Experience with MS Excel, strong analytical and organizational skills, and excellent written and verbal communication.
• Ability to lead projects, present complex scientific data clearly, and influence decisions in a global matrix environment.

Nice to have

• At least 1 year of clinical or patient-care experience.
• Familiarity with epidemiologic principles for case-series evaluation.
• Experience with computer-assisted safety-data analysis, public-health surveillance tools, SAS JMP, statistics, system analytics, information systems engineering, or machine learning.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• Retirement pension and 401(k) savings plans.
• Eligibility for a long-term incentive program.
• Vacation, sick time, holidays, personal and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time-off.