Director, Medical Safety Assessment Physician, Neuroscience

About the role

Bristol Myers Squibb is seeking a Safety Lead to oversee safety activities and benefit-risk strategies for assigned BMS compounds and programs. This role involves leading safety activities, preparing and reviewing safety documents, managing safety signals, and supporting regulatory and postmarketing activities.

Responsibilities

• Lead safety activities and benefit-risk strategies for assigned BMS compounds and programs
• Chair the Product Safety Management Team(s)
• Oversee, prepare and/or review aggregate safety review documents and safety sections of clinical trial documents and regulatory filings
• Evaluate and manage safety signals emerging from various data sources
• Develop and document safety strategies
• Manage safety labeling activities for assigned products
• Provide input to regulatory product labeling
• Participate in cross-functional labeling team meetings and provide regional safety labeling support
• Lead process improvement projects
• Support the EU Qualified Person for Pharmacovigilance (PV) or other regional or local Qualified Person for PV
• Support R&D publication strategy and ensure safety input to publications/presentations
• Act as the Safety Subject Matter Expert for input to regulatory product labeling
• Represent PS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings
• Ensure efficiency and compliance with global regulatory requirements and BMS cost-effectiveness goals
• Promote collegiality and teamwork among peers
• Mentor/support colleagues as a positive change agent

Qualifications

• MD or equivalent degree required
• Postgraduate qualification or experience in psychiatry or neurology preferred
• 3+ years in Pharmacovigilance (PV) or relevant pharmaceutical or biomedical field
• Understanding of the drug development process
• Knowledge of PV and ability to apply knowledge to evaluate safety concerns
• Proficient ability to leverage available tools for investigating safety concerns
• Strong scientific analytical reasoning skills
• Excellent attention to detail
• Behavioral competencies necessary to work and lead within a complex matrix environment
• Excellent verbal and written communication skills