Senior Manager, Pharmacovigilance Scientist, Bristol-Myers Squibb Company, Princeton, NJ. Support Medical Safety Assessment Physician leading signal detection activities for a product's emerging safety profile. Prepare and write Pharmacovigilance sections of aggregate safety documents (e.g., Development Safety Update Reports, Periodic Benefit Risk Evaluation Reports) and analyze data for the Reference Safety Information section of the Investigator Brochure. Write and analyze data for ad hoc responses to health authorities, with oversight. Analyze data and prepare documentation to support label updates for assigned products. Support Safety input for regulatory product labeling. Support the European Union Qualified Person for Pharmacovigilance or other regional or local Qualified Person for safety issues relating to assigned products. 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. Elevate issues impacting key Safety Management Team activities, milestones, and documents to the Safety Management Team Chair with oversight. Execute the strategy for signal evaluation (e.g., case-series, literature review, Health Authority and claims database). Partner with Safety Management Team Chair on the evaluation and 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 Serious Adverse Reactions for inclusion in the Reference Safety Information section of the Investigator Brochure, including presentation to Safety Management Team to ensure alignment. Author the table for the Reference Safety Information section of the Investigator Brochure, for less complex products with oversight. Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile, with oversight as needed. Support preparation for regulatory inspections and audits with 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. Build cross functional relationships with SMT membership and stakeholders.

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. $150,829/yr - $197,590/yr.

MINIMUM REQUIREMENTS:

Bachelor’s degree or foreign equivalent degree in Chemistry, Healthcare or a related field, and three (3) years of post- baccalaureate experience.

Must have experience with/in:

• Drug safety, medical writing, signal detection, scientific background, clinical trials, and project management skills; and
• Medical concepts, safety activities in drug development, postmarketing, global safety health authority requirements.

The required skills do not need to be maintained over the full term of required experience. May work remotely within normal commuting distance of Princeton, NJ.

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.

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