Pharmacovigilance Scientist

Posted:
10/3/2024, 10:17:08 PM

Location(s):
New Jersey, United States ⋅ Madison, New Jersey, United States

Experience Level(s):
Mid Level ⋅ Senior

Field(s):
Medical, Clinical & Veterinary

Workplace Type:
Hybrid

Working with Us
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 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: careers.bms.com/working-with-us.

Employer:       Bristol-Myers Squibb Company

Position:          Pharmacovigilance Scientist (ref.# 7842)

Location:         5 Giralda Farms, Madison, NJ 07940

Duties:  Support Medical Safety Assessment Physician (MSAP) leading signal detection activities for a product's emerging safety profile. Prepare and write PV sections of aggregate safety documents such as DSUR (development safety update report) and PBRER (periodic benefit-risk evaluation report) and analyze data for the RSI (reference safety information) section of the IB (investigator’s brochure).  Write and analyze data for ad hoc responses to health authorities, with oversight. Document signal by Safety Topic Review/ Signal Report. Analyze data and prepare documentation to support label updates for assigned products, with oversight. Support Safety input for regulatory product labeling. Support the EU QPPV (qualified person responsible for pharmacovigilance) or other regional or local Qualified Person for safety issues relating to assigned products. Utilize knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA (health authority) commitments, and individual functional area responsibilities. Utilize knowledge of medical concepts, safety activities in drug development and post marketing and global safety health authority requirements; medical-scientific data from a broad range of disciplines such as clinical trial laboratory data, nonclinical data, post marketing reports, scientific literature, and regulatory documents. Perform core surveillance activities, signal assessment according to the product stage of development for multiple compounds, with oversight. Lead Safety Data Review Meetings (SDRM) in the review and evaluation of clinical data to support signal detection. Appropriately elevate issues impacting key SMT (senior management team) activities, milestones, and documents to the SMT Chair. 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. Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data. Execute strategy for signal evaluation such as case-series, literature review, and HA/ claims database. Partner with SMT Chair on the evaluation & management of signals emerging from any data source. Author the Safety Topic Review/Signal Report and tracks signals for other means of communication. Perform the review and evaluation of SARs for inclusion in the IB RSI (reference safety information), including presentation to SMT to ensure alignment. Author the IB RSI table, for less complex products. Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging post marketing safety profile. May work remotely 2-3 days per week within normal commuting distance of Madison, NJ.

Requirements: Master’s degree in pharmaceutical chemistry, chemistry, pharmacy or a related field plus 4 years of post-baccalaureate experience or in alternative bachelor’s degree in pharmaceutical chemistry, chemistry, pharmacy or a related field plus 6 years of post-baccalaureate experience Experience must include the following skills: signal detection, safety database fluency, and aggregate report authoring. The required skills do not need to be maintained over the full term of required experience.

The starting compensation for this job is a range from $145,917/year – 197,417/year, plus incentive cash and stock opportunities (based on eligibility).

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.

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 BMS Careers Site link is not copy and pasting correctly, please add manually using the following address: https://jobs.bms.com/careers/join.

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 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 [email protected]. 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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