Associate Direc. Patient Safety Scientist

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Challenging. 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. 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: careers.bms.com/working-with-us.

Perform core signal detection activities and elevate program or portfolio issues impacting key Safety Management Team (SMT) programs, priorities, resources, and milestones. Draft the early safety strategy plan, the Early Development Safety Roadmap (EDSR). Author safety data query responses, author and contribute to specific PV sections of the Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), and health authority (HA) submission documents for new and expanded indications (Filing Activities). Ensure pharmacovigilance regulatory compliance. Lead Safety Data Review (SDR) Teams in the review and evaluation of clinical data to support signal detection. Specially, this position will perform the following duties:

• Lead signal detection activities for a product’s emerging safety profile.
• Provide strong medical writing support for PV sections of safety aggregate reports (eg, DSUR, PBRER) and analyze data for the RSI section of the IB. Collaborate with MSAP to author and analyze data for ad hoc responses to health authorities.
• Contribute to the development of the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Documents signal assessment in a Signal Report drafting a preliminary conclusion.
• Develop strategies for safety data collection in clinical trials to further characterize adverse events of interest.
• Analyze data and prepares documentation to support label updates for assigned products.
• Support the European Union Qualified Person for Pharmacovigilance (EU QPPV) or other regional or local Qualified Person for safety issues relating to assigned products.
• Collaborate with the Pharmacovigilance Centre of Excellence (PVCoE) to develop report requirements and other customized safety data visualizations.
• Serve as liaison to Medical teams for AIMS (Asset/Indication Medical Strategy), publications, and investigator sponsored research
• Lead core surveillance activities, signal assessment according to the product stage of development for multiple compounds, with oversight, as needed.
• Lead the creation and updates of EDSR proactively collect, assess, identify, characterize, manage, and minimize emerging safety concerns across all aggregated clinical trials of a product during its development.
• Review of clinical documents for safety content (i.e. protocols, protocol amendments, clinical study reports).
• Contribute to the Filing activities for marketing authorization applications (MAA), new drug applications (NDA).
• Contribute to specified PV sections of the DSURs, PBRERs and safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries, with limited or no oversight, as needed.
• Provide guidance to junior scientists’ for reviewing and authoring of safety data/ad hoc queries and other documents.
• Contribute to the strategy and perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
• Provide input for the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Partner with SMT Chair on the evaluation & management of signals emerging from any data source. Authors the Signal Report and tracks signals for other means of communication, with limited or no oversight, as needed.
• Facilitate the review and evaluation of Serious Adverse Reactions for inclusion in the Investigator Brochure Reference Safety Information (IB RSI), including presentation to SMT to ensure alignment. Author the IB RSI table for multiple products with limited or no oversight.
• Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile, with limited or no oversight.
• Assist the Patient Safety Scientist team Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS.
• Support preparation for regulatory inspections and audits for evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
• Support process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.
• Support the development of strategic plans for safety differentiation of BMS products. (R1592960)

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. $150,300/yr - $203,340/yr.

May work 5 days per two weeks within normal commuting distance of Princeton, NJ.

MINIMUM REQUIREMENTS:

Requires Bachelor's degree in Pharmaceutical Management, Pharmacy, Health Science, or a related field plus 6 years of experience.

Experience must include the following:

• knowledge of clinical trial
• postmarketing safety
• marketing authorization filing and submissions
• medical writing, protocol and clinical document review,
• signal detection

The skills, knowledge and/or experience need not be maintained over the full term of experience required.

To apply, email resume and reference R1592960 in the subject line of the email to resume.com@bms.com.

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site (https://jobs.bms.com/careers/join).

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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 Careers
With 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 a supportive culture, promoting global participation 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 an 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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: https://careers.bms.com/california-residents/

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