Director, Medical Safety Assessment Physician

3+ years

Not Disclosed

Madison Princeton Junction Uxbridge

10 Nov. 27, 2024

Job Description

Job Type: Full Time Education: MD or equivalent required (specialization in immunology or internal medicine preferred). Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director, Medical Safety Assessment Physician (Immunology)

Locations:

Princeton, NJ, US
Madison - Giralda, NJ, US
Uxbridge, GB

Job Type: Full-time
Posted: 14 days ago
Requisition ID: R1584177

About the Role: As a Director at Bristol Myers Squibb, you will play a pivotal role in leading safety activities and benefit-risk strategies for assigned Immunology compounds. You will manage safety assessments, review clinical documents, and ensure regulatory compliance while overseeing cross-functional teams. This is an opportunity to contribute to innovative drug development that transforms patient lives.

Key Responsibilities:

Lead safety and benefit-risk strategies for Immunology products.
Chair product Safety Management Teams (SMTs) and manage signal evaluations.
Prepare safety-related documents for clinical trials and regulatory filings.
Drive safety labeling activities and provide expertise on product safety profiles.
Support postmarketing safety activities, including risk management strategies.
Lead process improvements and mentor colleagues for professional development.

Clinical & Postmarketing Support:

Guide safety evaluations in clinical development, ensuring risk management strategies are executed.
Provide safety input for global regulatory submissions, clinical protocols, and publications.
Manage postmarketing safety activities, focusing on the identification and resolution of emerging safety issues.

Cross-Functional Engagement:

Collaborate with various departments, ensuring alignment on safety strategies and product risk management.
Lead training initiatives and liaise with legal, marketing, and manufacturing teams.

Qualifications:

Degree: MD or equivalent required (specialization in immunology or internal medicine preferred).
Experience: 3+ years in pharmacovigilance (PV) or a relevant pharmaceutical field.
Skills: Strong scientific analysis, attention to detail, and ability to lead in a matrix environment.

Why Bristol Myers Squibb? Bristol Myers Squibb offers a culture of innovation and inclusivity where every employee is empowered to make a meaningful impact. Join us to be part of life-changing work that improves the health and well-being of patients worldwide.

Work Environment:

Flexible work model depending on role requirements.
BMS is committed to equal employment opportunities and provides accommodations for candidates with disabilities.

Application Link:
For more information, visit BMS Careers.

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Director, Medical Safety Assessment Physician

Job Description

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