5 дней назад
Director, Signal Detection Scientist (Pharmacovigilance)
164 000 - 282 900$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Director, Signal Detection Scientist (Pharmacovigilance): Leading proactive detection and evaluation of emerging safety signals from post-marketing pharmaceutical data with an accent on signal validation, aggregate safety reviews, and global regulatory databases. Focus on developing computer-assisted surveillance methodologies, analyzing complex safety data, and influencing cross-functional safety decisions.
Location: Horsham, Pennsylvania; Raritan, New Jersey; or Titusville, New Jersey, United States. The role may also be posted for the United Kingdom. Up to 10% domestic and international travel is required.
Base pay: $164,000–$282,900 per year, plus eligibility for incentive, retirement, and savings plans.
Company
Johnson & Johnson MedTech develops healthcare solutions and medicines through its Innovative Medicine and MedTech businesses.
What you will do
- Lead systematic signal detection and trend assessment for complex and innovative pharmaceutical products using aggregate safety data.
- Lead signal validation strategy discussions with Global Safety Strategy & Risk Management and other stakeholders.
- Prepare safety reviews and summary analyses, communicate findings to Medical Safety Officers and Safety Management Teams, and recommend further evaluation.
- Develop product-specific surveillance plans and guide analysis of data from FDA AEMS, WHO VigiBase, EMA EudraVigilance, company databases, claims, and electronic medical records.
- Drive programmatic surveillance, educational materials, stakeholder training, and improvements to reporting and data-presentation practices.
- Mentor Signal Detection Scientists and provide technical leadership when evaluating new tools, data sources, and methodologies.
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 industry 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, post-marketing aggregate reviews, 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, case-series evaluation, public health surveillance, or a related Master of Public Health background.
- Knowledge of statistics, systems analytics, information systems engineering, or machine learning.
Culture & Benefits
- Inclusive work environment guided by the company’s Credo and focused on healthcare innovation.
- Retirement pension and 401(k) savings plans, subject to plan terms.
- Long-term incentive program eligibility.
- Paid vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.
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