Associate Director, Medical Safety Assessment Physician, Cell Therapy
This role is part of the Worldwide Patient Safety (WWPS) group, responsible for ensuring the safety of Bristol Myers Squibb medicines.
Responsibilities
- General Product Support
- Support safety activities and benefit‑risk strategies for assigned BMS compounds.
- Prepare aggregate safety review documents such as DSURs and PBRERs, and safety sections of clinical trial documents (protocols, CSRs, IBs, ICFs).
- Evaluate and manage signals from any data source, documenting outcomes in Safety Topic Reviews or Signal Reports.
- Support safety labeling activities and provide safety input for regulatory product labeling.
- Participate in cross‑functional labeling team meetings and provide regional safety labeling support.
- Support the EU QPPV or other regional Qualified Person for PV on safety issues.
- Support R&D publication strategy and ensure safety input to publications and presentations.
- Clinical Development Support
- Act as the global safety lead for assigned compounds in development.
- Provide safety lead support for global submission document production.
- Contribute safety input to clinical development plans, protocols, and other regulatory documents.
- Support risk management strategy, safety table shells, integrated safety data reviews, and safety-focused publication development.
- Perform medical safety review of periodic safety submissions.
- Support safety strategy preparation for pre‑submission, advisory committee, and scientific advice meetings.
- Postmarketing Support
- Support the global safety lead for marketed compounds and global postmarketing safety activities.
- Provide medical safety and benefit‑risk input for safety aggregate reports and product renewal submissions.
- Oversee risk management strategies and RMP elements, and evaluate safety signals.
- Prepare Safety Topic Review/Signal Reports and ad‑hoc regulatory responses.
- Ensure safety labeling reflects the emerging postmarketing safety profile.
- Department Activities
- Prepare for regulatory inspections, evaluate current processes, and assess alignment with regulatory expectations.
- Assist in issue management and crisis management initiatives.
- Cross‑Functional Activities
- Support manufacturing quality and co‑author integrated health hazard assessments.
- Develop safety data communications and interpretation for global stakeholders.
Qualifications
- MD or equivalent required.
- Postgraduate qualification or experience in internal medicine, immunology, oncology, or a related specialty desirable.
- Experience in clinical research, observational research, or clinical practice considered an asset.
- Strong scientific analytical reasoning skills.
- Ability to manage multiple projects concurrently.
- Excellent attention to detail.
- Strong verbal and written communication skills.
- Experience working and leading in a complex matrix environment.
Travel
Occasional domestic and international travel required, approximately once every three months, with overseas travel once per year.
Benefits
We offer a wide variety of competitive benefits, services, and programs to support employees in their professional and personal goals.
Equal Employment Opportunity
Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws.
Disability Accessibility
BMS is Disability Confident – Employer.
Data Protection
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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