Therapeutic Area Head (Director), Medical Safety Review, Oncology
Company: Bristol-Myers Squibb
Location: Princeton
Posted on: February 25, 2021
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Job Description:
Therapeutic Area Head (Director), Medical Safety Review,
Oncology Princeton - NJ - US At Bristol Myers Squibb, we are
inspired by a single vision - transforming patients' lives through
science.--In oncology, hematology, immunology and cardiovascular
disease - and one of the most diverse and promising pipelines in
the industry - each of our passionate colleagues contribute to
innovations that drive meaningful change. We bring a human touch to
every treatment we pioneer. Join us and make a difference.
Functional Area Description The Worldwide Patient Safety group is
responsible for ensuring the safety of our medicines: The Worldwide
Patient Safety group is responsible for pharmacovigilance and
pharmaco-epidemiology deliverables including single case and
aggregate safety monitoring, safety reporting, contribution to
benefit-risk assessment, risk management planning and strategy, and
execution of certain post-marketing commitments and ensuring
compliance with global regulatory requirements. Summary: The TA
Head - Medical Safety Review provides oversight of all products
within the therapeutic area, manages and develops the Medical
Review Safety Physicians (MRSPs) within the therapeutic area. May
have own product responsibilities for which provides high quality
medical review of ICSRs including the determination of regulatory
reportability of clinical trial cases and spontaneous reports.
Performs signal detection based on ICSRs and discusses with
relevant stakeholders for further action. Represents MR in
cross-functional meetings and makes informed decisions within the
area of expertise. If applicable, provides oversight of MR of
assigned TA at the ICSR Processing offshore vendor. Position
Responsibilities Management: Provides oversight of all products
within the designated therapeutic area; manages and develops the
Medical Review Safety Physicians (MRSPs) within the therapeutic
area. Provides training and act as mentor to Medical Directors and
Associate Medical Directors. Takes the lead in convening teams to
assure consistent application of work practices and processes.
Medical Review: For products within the assigned TA, provides
medical review of individual serious spontaneous reports of adverse
events. Provides medical review and performs causality assessment
and determines regulatory reportability of clinical trial cases for
assigned products and across therapeutic areas. Provides oversight
of single case processing vendor re: medical review for products of
responsibility. As applicable, leads all quality monitoring efforts
related to medical review. Compliance: Ensures complete and timely
reporting of medical cases to regulatory authorities globally for
products of responsibility. Collaborate with QST to ensure
consistency of work practices and SOPs. Demonstrates ability to
apply BMS operating philosophy and operate within company policies
and procedures and appropriate regulations. Collaboration: Partners
with WWPS personnel (AE processors, PV scientists, ESR Scientists
and Medical Safety Assessment Physicians) and personnel from other
functions and external stakeholders as the point of contact on
medical review-related topics, evaluating the safety profile of BMS
compounds within the therapeutic are of responsibility. Identifies
potential safety signals and informs the appropriate MSAP of all
potentially important cases and issues.-- Development/Processes:
Deals with safety-related issues using critical medical and
regulatory analytical strategies to develop optimal solutions. Is
an active, high-energy proponent of the Company's commitment to
public health. Influences and impacts others through clear reasoned
argument, helps to drive consensus of opinion, and catalyzes action
to meet critical regulatory objectives. Represents WWPS within
areas of responsibility, competence and experience. Ensures that
the above tasks are performed in the most efficient manner possible
commensurate with quality, accuracy, and safety in accordance with
company cost effectiveness goals. (Disclaimer: The responsibilities
listed above are only a summary and other responsibilities will be
requirements as assigned.) Qualifications Education Required: MD or
Equivalent. Board certification and medical specialty preferred.
Minimum 2-4 years in clinical practice or relevant setting. Minimum
5 years of pharmaceutical industry experience of which at least 3
year was dedicated to the medical evaluation and reporting of
individual adverse events. Key Competency Requirements
Knowledgeable and skilled in medicine and pharmaceutical product
safety. Experience applying medical knowledge to the interpretation
of individual case review; experience with reporting of individual
adverse events. Familiarity with applicable regulatory guidelines.
Experience working in a team environment, including supporting
other team members when necessary; promote collegiality and
teamwork among peers. Ability think clearly and decisively and
present independent, reasoned solutions to identified safety
issues, helps to drive consensus of opinion, and catalyzes action
to meet critical regulatory objectives. Demonstrated creative
problem solving skills that enact change and drive continuous
improvement. Seeks to develop self and others. Creates, aligns and
communicates clear objectives with organizational goal. Excellent
oral, and written English skills.-- Excellent communication,
interpersonal, people and time management skills. Demonstrated
flexibility, open mindedness and adaptability in a rapidly changing
environment. Ability to build and manage interrelationships by
motivating and inspiring others.-- Ability to operate
autonomously.-- Travel Required: Around the world, we are
passionate about making an impact on the lives of patients with
serious diseases. Empowered to apply our individual talents and
diverse perspectives in an inclusive culture, our shared values of
passion, innovation, urgency, accountability, inclusion and
integrity bring out the highest potential of each of our
colleagues. 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. W e're creatinginnovative
medicines for patients fighting serious diseases. We're also
nurturing our own diverse team with inspiring work and challenging
career options. No matter the role, each one of us makes a
contribution. And that makes all the difference.
Keywords: Bristol-Myers Squibb, Trenton , Therapeutic Area Head (Director), Medical Safety Review, Oncology, Healthcare , Princeton, New Jersey
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