Director, Medical Safety Assessment Physician
Company: Disability Solutions
Location: Princeton
Posted on: October 19, 2024
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Job Description:
Working with UsChallenging. Meaningful. Life-changing. Those
aren't words that are usually associated with a job. But working at
Bristol Myers Squibb is anything but usual. Here, uniquely
interesting work happens every day, in every department. From
optimizing a production line to the latest breakthroughs in cell
therapy, this is work that transforms the lives of patients, and
the careers of those who do it. You'll get the chance to grow and
thrive through opportunities uncommon in scale and scope, alongside
high-achieving teams rich in diversity. Take your career farther
than you thought possible.Bristol Myers Squibb recognizes the
importance of balance and flexibility in our work environment. We
offer a wide variety of competitive benefits, services and programs
that provide our employees with the resources to pursue their
goals, both at work and in their personal lives. Read more:
.Director, Medical Safety Assessment Physician
(Immunology)Functional Area DescriptionThe Worldwide Patient Safety
(WWPS) group is responsible for ensuring the safety of our
medicines. WWPS pharmacovigilance and pharmacoepidemiology
deliverables include single case and aggregate safety monitoring,
safety reporting, contributing to benefit-risk assessment, risk
management planning and strategy, execution of certain
postmarketing commitments, and ensuring compliance with global
regulatory requirements.Position Summary -- Lead safety activities
and benefit-risk strategies for assigned BMS compounds/programs in
the Immunology Therapeutic Area (TA) and chair the product Safety
Management Team(s). -- Oversee, prepare, and/or review aggregate
safety review documents as well as safety sections of relevant
clinical trial documents and regulatory filings. -- Lead team in
the evaluation & management of signals emerging from any data
source. Develop strategy for signal evaluation and document
outcome. -- Lead safety labeling activities for assigned
products/program. Act as the Safety Subject Matter Expert for input
to regulatory product labeling. Participate/provide input at
cross-functional labeling team meetings and provide regional safety
labeling support. -- Lead process improvement projects. Assist the
Medical Safety Assessment (MSA) TA Head/Lead in developing and
maintaining state-of-the-art Pharmacovigilance (PV) processes and
procedures within BMS Drug Development and WWPS. -- Support the EU
Qualified Person for PV or other regional or local Qualified Person
for PV relative to issues relating to assigned products. -- Provide
input to Drug Development publication strategy/plan & ensure safety
input to publications/presentations. -- Actively drive safety
strategy preparation and represent WWPS at Health Authority (HA)
and Data Monitoring Committee (DMC) meetings. -- Ensure that the
above tasks are performed in the most efficient manner possible
commensurate with quality, accuracy, and timeliness and in
accordance with current global regulatory requirements and BMS cost
effectiveness goals. -- Promote collegiality and teamwork among
peers. Mentor/support colleagues as a positive change
agent.Position ResponsibilitiesGeneral Product Support -- Lead
safety activities and benefit-risk strategies for assigned BMS
compounds and chair the product SMT(s). -- Oversee, prepare, and/or
review aggregate safety review documents (eg, Development Safety
Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports
[PBRER]) and safety sections of relevant clinical trial documents
(eg, protocols, clinical study reports [CSR], investigator
brochures [IB], informed consent forms [ICF]) and regulatory
filings (eg, clinical trial applications, marketing authorization
applications). -- Lead team in evaluation & management of signals
emerging from any data source. Develop strategy for signal
evaluation (eg, case-series, literature review, HA/ claims
database). Document by Safety Topic Review/ Signal Report or other
means of communication. -- Lead safety labeling activities for
assigned products. Act as the Safety Subject Matter Expert for
input to regulatory product labeling. Participate/provide input at
cross-functional labeling team meetings and provide regional safety
labeling support. -- Support the EU QPPV or other regional or local
Qualified Person for PV relative to issues relating to assigned
products. -- Provide input to Drug Development publication
strategy/plan & ensure safety input to
publications/presentations.Clinical Development -- Act as the
global safety lead for assigned compounds in development. Provide
safety lead support for global submission document production.
Review draft summary documents. -- Lead medical safety development
and execution of benefit-risk management strategies for assigned
products. -- Provide safety input to clinical development plans,
study protocols, amendments, IB, statistical analysis plan, ICF,
CSR, responses to HA or institutional review board/ ethics
committee queries. -- Lead development of safety risk language,
risk management strategy, pre-filing safety activities including
safety table shells, integrated safety data review, integrated
safety summary document review, and safety-focused publication
development. -- Perform medical safety review of DSUR, annual
reports and other periodic safety submissions. -- Support safety
strategy preparation for pre-submission meetings, Advisory
Committee meetings, Scientific Advice meetings, DMC meetings,
etc.Postmarketing Support -- Act as the safety lead for assigned
marketed compounds and support global postmarketing safety
activities and submissions. -- Provide medical safety, benefit-risk
input for safety aggregate reports, product renewal submissions,
postmarketing study documents and reports, responses to HA queries.
-- Lead medical safety oversight of and execution of risk
management strategies and RMP elements for assigned products. --
Lead safety signal evaluation & management. Prepare and review
reports on safety signals (ie, Safety Topic Reviews/Signal Reports)
and ad hoc regulatory responses. -- Provide postmarketing safety
study guidance to other groups including epidemiology and medical
affairs including but not limited to investigator-sponsored
research, epidemiology studies, and non-interventional safety
studies. -- Ensure safety labeling adequately reflects emerging
postmarketing safety profile.Department Activities -- Lead process
improvement projects. Assist the MSA TA Head/Lead in developing and
maintaining state-of-the-art PV processes and procedures within BMS
Drug Development and WWPS. -- Support preparation for regulatory
inspections with evaluation of current processes and assess
alignment with regulatory expectations, guidelines, and mandates.
-- Assist the team and senior management in all forms of issue
management and crisis management. -- Liaise with all TA staff and
maintain an effective and collaborative patient safety team. --
Support hiring & orientation.Cross-Functional Activities -- Provide
input to strategic plans for safety differentiation of BMS
products. -- Prepare and provide training to BMS employees on
product safety profiles/issues. -- Act as WWPS liaison for assigned
products with BMS functions (Legal, Business Development,
Operations, Marketing, etc.). -- Support manufacturing quality.
Co-Author integrated health hazard assessments. -- Develop
communications of safety data & interpretation to BMS and external
parties, globally.Degree RequirementsMD/equivalent required.
Postgraduate qualification or experience in internal medicine,
immunology, or related specialty desirable.Experience
Requirements3+ years in PV or relevant pharmaceutical or biomedical
field (eg, Medical, Clinical, Regulatory) is strongly preferred.
Other relevant experiences & accomplishments considered, such as
roles in clinical research, observational research & clinical
practice experience.Key Competency Requirements -- Understanding of
the drug development process. -- Knowledge of PV and ability to
apply knowledge to evaluation of safety concerns and minimization
of patient risk throughout the life cycle of a drug product. --
Proficient ability to leverage the range of available tools to
investigate safety concerns, including the science of observational
research. -- Understanding of regulatory requirements for safety
assessment and action. -- Strong scientific analytical reasoning
skills. -- Ability to work on multiple projects in parallel. --
Excellent attention to detail. -- Behavioral competencies necessary
to work and lead within a complex matrix environment. -- Excellent
verbal and written communication skills.If you come across a role
that intrigues you but doesn't perfectly line up with your resume,
we encourage you to apply anyway. You could be one step away from
work that will transform your life and career. Uniquely Interesting
Work, Life-changing CareersWith a single vision as inspiring as
Transforming patients' lives through science--- , every BMS
employee plays an integral role in work that goes far beyond
ordinary. Each of us is empowered to apply our individual talents
and unique perspectives in an inclusive culture, promoting
diversity in clinical trials, while our shared values of passion,
innovation, urgency, accountability, inclusion and integrity bring
out the highest potential of each of our colleagues.On-site
Protocol BMS has a diverse occupancy structure that determines
where an employee is required to conduct their work. This structure
includes site-essential, site-by-design, field-based and
remote-by-design jobs. The occupancy type that you are assigned is
determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned
facility. Site-by-design roles may be eligible for a hybrid work
model with at least 50% onsite at your assigned facility. For these
roles, onsite presence is considered an essential job function and
is critical to collaboration, innovation, productivity, and a
positive Company culture. For field-based and remote-by-design
roles the ability to physically travel to visit customers, patients
or business partners and to attend meetings on behalf of BMS as
directed is an essential job function. BMS is dedicated to ensuring
that people with disabilities can excel through a transparent
recruitment process, reasonable workplace
accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace
accommodation/adjustment prior to accepting a job offer. If you
require reasonable accommodations/adjustments in completing this
application, or in any part of the recruitment process, direct your
inquiries to . Visit to access our complete Equal Employment
Opportunity statement. BMS cares about your well-being and the
well-being of our staff, customers, patients, and communities. As a
result, the Company strongly recommends that all employees be fully
vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest
and conviction records, pursuant to applicable laws in your area.If
you live in or expect to work from Los Angeles County if hired for
this position, please visit this page for important additional
information: Any data processed in connection with role
applications will be treated in accordance with applicable data
privacy policies and regulations.
Keywords: Disability Solutions, Trenton , Director, Medical Safety Assessment Physician, Healthcare , Princeton, New Jersey
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