Associate Director, Medical Safety Assessment Physician, Cell Therapy

Description

The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements.

Position Summary / Objective

• Support safety activities and benefit-risk strategies for assigned BMS compounds/ program and chair the product Safety Management Team(s).
• Prepare aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
• Support evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation and document outcome.
• Support safety labeling activities for assigned products. Support Safety input for regulatory product labeling. Participate/ Provide input at cross-functional labeling team meetings and provide regional safety labeling support.
• Support the EU Qualified Person for Pharmacovigilance (PV) or other regional or local Qualified Person for PV relative to issues relating to assigned products.
• Ensure that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness goals.
• Promote collegiality and teamwork among peers. Mentor/Support colleagues as a positive change agent.

Position Responsibilities

General Product Support

• Support safety activities and benefit-risk strategies for assigned BMS compounds.
• Prepare aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]).
• Support evaluation & management of signals emerging from any data source (eg, case-series, literature review, Health Authority (HA)/ claims database). Document by Safety Topic Review/ Signal Report or other means of communication.
• Support safety labeling activities for assigned products. Support Safety input for regulatory product labeling. Participate/ Provide input at cross-functional labeling team meetings and provide regional safety labeling support.
• Support the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
• Support R&D publication strategy/ plan & ensure safety input to publications/ presentations.

Clinical Development

• Support the global safety lead for assigned compounds in development. Provide safety lead support for global submission document production.
• Support medical safety development and execution of benefit-risk management strategies for assigned products.
• Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries.
• Support development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, safety-focused publication development.
• Perform medical safety review of development update safety reports, annual reports and other periodic safety submissions.
• Support safety strategy preparation for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc.

Postmarketing Support

• Support the global safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions.
• Provide medical safety, benefit-risk input for safety aggregate reports, product renewal submissions, postmarketing study documents and reports, responses to HA queries.
• Support medical safety oversight of and execution of risk management strategies and RMP elements for assigned products.
• Support safety signal evaluation & management. Prepare reports on safety signals (ie, Safety Topic Reviews/ Signal Reports) and ad hoc regulatory responses.
• Ensure safety labeling adequately reflects emerging postmarketing safety profile.

Department Activities

• Support preparation for regulatory inspections with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
• Assist the team and senior management in all forms of issue management and crisis management.

Cross-Functional Activities

• Support manufacturing quality. Co-Author integrated health hazard assessments.
• Support development of safety data communications & interpretation to BMS and external parties, globally.

Degree Requirements

• MD/equivalent required. Postgraduate qualification or experience in internal medicine, immunology, oncology, or related specialty desirable.
• Other relevant experiences & accomplishments considered, such as roles in clinical research, observational research & clinical practice experience.

Key Competency Requirements

Strong scientific analytical reasoning skills.

Ability to work on multiple projects in parallel.

Excellent attention to detail.

Behavioral competencies necessary to work and lead within a complex matrix environment.

Excellent verbal and written communication skills.

Travel Required

Occasional domestic/international travel (eg, once every 3 months) and overseas (eg, once a year)

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.

Supporting People with Disabilities

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 . Visit to access our complete Equal Employment Opportunity statement.

Bristol Myers Squibb is Disability Confident – Employer

A UK Government scheme

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

R1604397 : Associate Director, Medical Safety Assessment Physician, Cell Therapy