Director, Signal Detection Scientist

Johnson & Johnson Innovative Medicine•Horsham, PA

2d•$164,000 - $282,900•Hybrid

About The Position

The Director, Signal Detection Scientist will lead the implementation of the Signal Management Group surveillance strategies for proactive and systematic detection and evaluation of new safety signals and emerging trends from post-marketing safety data for complex pharmaceutical products (e.g., large innovative programs, new therapeutic areas, or complex business partner relationships). These activities include the development, evaluation, piloting, as well as use of novel, computer-assisted tools and methodologies for signal detection and analysis of internal company safety data, international regulatory safety databases, and other data sources, e.g., claims and electronic medical records. The Director, Signal Detection Scientist will function at a high level of safety and scientific acumen, competence, and leadership to independently develop and implement product-specific surveillance plans, perform post-marketing signal detection activities, including signal validation, and participate in communication of emerging signals in forums, such as the Product Team Meetings and Safety Management Team Meetings. This individual will function at a high level of independence and consistently deliver high-quality results with minimal guidance, quickly building alliances and independently influencing other safety partners to shape strong decisions/outcomes. The Director, Signal Detection Scientist will also participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis and may also perform activities supporting signal evaluation, such as ad hoc data mining of FDA AEMS, WHO VigiBase, and EMA EudraVigilance databases. This role also may involve leadership and support of exploration of new signal detection methodologies, tools, and data sources to further the science of safety surveillance.

Requirements

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.

Nice To Haves

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.

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.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (or 48/56 hours in CO/WA)
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year