Pharmaceutical Research & Development, L.L.C., a member of the Johnson
& Johnson Family of Companies, is recruiting for a Signal Management Physician.
This position will be based in Horsham, PA (strongly preferred), Titusville,
NJ, Raritan NJ, Springhouse, PA, or Morris Plains, NJ. Up to 10% travel is required.
the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters
most is helping people live full and healthy lives. We focus on treating,
curing and preventing some of the most devastating and complex diseases of our
time. And we pursue the most promising science, wherever it might be found.
Research & Development, LLC discovers and develops innovative medical solutions
to address important unmet medical needs in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
are Janssen. Our mission drives us. Our patients inspire us. We collaborate
with the world for the health of everyone in it.
The objective of
this position is to implement Signal Management Group (SMG) surveillance
strategies for proactive and systematic detection and evaluation of new safety
signals and emerging trends from post-marketing safety data. These activities
include the evaluation, piloting, as well as use of novel, computer-assisted
tools and methodologies for analysis of internal company safety data,
international regulatory safety databases, and other data sources, e.g. claims
and electronic medical records and social media.
This position, in
partnership with other SMG physicians and scientists, develops and implements
product-specific surveillance plans, performs post-marketing signal detection
activities, including signal validation, and participates in communication of
emerging signals in forums, such as the Product Team Meeting, Signal Management
Teams, and monthly Product Quality Meetings. This position will also
participate in the development of strategies for signal evaluation, and may
include performing activities supporting signal evaluation, such as case
definition development (including database query criteria), review of the
signal tracking system, ad hoc data mining FAERS, Vigibase, and SCEPTRE, and
narrative text mining.
- Identify and assess
(validate) new safety signals and trends by conducting systematic reviews of
aggregate data with a focus on spontaneous adverse event reports. This includes
signal detection activities in safety platforms, including SMART, lot alerts
system, routine and ad hoc data mining in Empirica Signal, and signal entry to
- Prepare reviews of
topics and summary analysis reports of safety data, in consultation with the
recommendations for further evaluation.
- Work with key customers and business partners
(MSOs, PVERs, and SSPs) in developing and implementing product-specific surveillance
- Participate as
member of the matrix teams to address product specific safety issues, assist in
the development of signal evaluation strategies, and participate in signal
- Communicate findings
from routine and ad hoc signal detection and assessment activities.
- Assist in the
development and implementation of programmatic surveillance of adverse event
reports for potential safety and product quality issues.
- Assist in the
evaluation of novel, computer-assisted tools and methodologies for analysis of
safety data, including piloting new data source and methodologies.
- A Medical degree
- A minimum of 2
years of industry experience in drug safety or related area is required
certification is required, preferably in a recognized primary care specialty (internal
medicine or subspecialty, pediatrics, preventive medicine or Family Medicine).
understanding of the strengths and limitations of company and regulatory safety
databases is preferred
- Familiarity with
applied epidemiologic principles of case series evaluation, and
computer-assisted methodologies for safety data analysis is preferred
- An in-depth
understanding of global health authority regulations and guidances surrounding
the processing, reporting and evaluation of adverse events is required
understanding in single case processing, aggregate data review and evaluation
of drug safety issues, core labeling, preparation and review of Periodic Safety
Review are required.
- Knowledge of
multiple adverse event dictionaries is required
- Knowledge in
public health surveillance and tools (relevant work experience or MPH or
equivalent) is preferred
- Ability to thrive in a global, matrix environment
- Ability to manage high workload and critical issues
United States-Pennsylvania-HorshamOther Locations
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Morris Plains, North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function
Drug & Product Safety Science