Responsibilities:

• Lead signal detection activities and assess new safety signals and trends for assigned complex/innovative products using the Company safety platforms through systematic reviews of aggregate safety data, e.g., spontaneous and noninterventional adverse event reports.
• Lead signal validation activities including strategy discussions, collaborating with Global Safety Strategy & Risk Management (GSSRM) and other stakeholders as necessary.
• Prepare high-quality reviews of topics and summary analysis reports of safety data. Communicate findings to Medical Safety Officers and the Safety Management Teams (SMTs) and provide recommendations for further evaluation, as applicable.
• Provide guidance and work with key customers and business partners (physicians, scientists) in developing and implementing product-specific surveillance plans.
• Demonstrate leadership in the SMT and other cross-functional forums and provide support as needed. Support SMT activities (e.g., preparing and presenting data) and provide input and review key regulatory or clinical documents, as appropriate.
• Leverage expert product knowledge to participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis. May also perform activities supporting signal evaluation, such as ad hoc data mining of FDA AEMS, WHO VigiBase, and EMA EudraVigilance and the Global Safety Database.
• Drive the development and implementation of programmatic surveillance of adverse event reports for potential safety and product quality issues.
• Drive the development of educational materials and provision of training of stakeholders and new personnel in the Signal Management Group (SMG)
• Provides mentoring to the Signal Detection Scientist, Associate Director.
• Together with the SMG Team Lead, evaluate novel computer-assisted tools and methodologies for analysis of safety data, including piloting new data sources and methodologies.
• Drive technical/intellectual leadership across SMG when exploring, identifying, and leading best practices on how to present data, prepare reports, and improve efficiencies.
• May have indirect people management responsibility when leading programs.

Qualifications:

Required:

• Advanced Healthcare-related Degree (e.g., RN, PharmD) is required with a minimum of 9 years industry experience in pharmacovigilance/drug safety or related area is required.
• A minimum of 3 years of industry experience in full-time pharmacovigilance signal detection is required.
• A minimum of 1 year of clinical/patient-care experience is required.
• In-depth understanding of signal detection systems and methodologies required.
• Understanding of global health authority regulations and guidance’s surrounding the processing, reporting and evaluation of adverse events is required.
• Understanding of the following is required: single case medical assessment; post-marketing aggregate adverse event data reviews; evaluations of drug safety issues; adverse event dictionaries; core labeling; Periodic Safety Review preparation.
• Ability to present complex data in a concise and understandable scientific manner is required.
• Ability to lead projects, influence, and shape decision making required.
• Ability to thrive in a global, matrix environment, collaborate with all levels and manage high workload and critical issues.
• Ability to manipulate data in platforms such as Excel is required.
• Must have excellent verbal and written communication skills.
• Must have strong organization and analytical skills.
• This position will require up to 10% domestic and international travel.

Preferred:

• Experience with SAS JMP, or related platforms is preferred.
• Familiarity with applied epidemiologic principles of case series evaluation and understanding of computer-assisted methodologies for safety data analysis is preferred.
• Knowledge in public health surveillance and tools (relevant work experience or Masters Public Health or equivalent) is preferred.
• Knowledge of statistics, or system analytics, information systems engineering, or machine learning is preferred.

Johnson & Johnson Commitment:

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

• Clinical Trials
• Consulting
• Critical Thinking
• Cross-Functional Collaboration
• Design Mindset
• Global Market
• Medicines and Device Development and Regulation
• Mentorship
• Pharmacovigilance
• Quality Control (QC)
• Quality Management Systems (QMS)
• Regulatory Affairs Management
• Report Writing
• Research Documents
• Safety Investigations
• Safety-Oriented
• Safety Reporting
• Serious Adverse Event Reporting

Preferred Skills:

• None listed