Senior Manager (Safety Ops/Safety Scientist)

Bristol Myers Squibb • Princeton, NJ

4d

About The Position

This position provides management oversight of Global Patient Safety case management, drug safety case management vendors, safety submission compliance, and cross-functional collaboration supporting risk management and pharmacovigilance activities. The role leads global Individual Case Safety Report (ICSR) activities in compliance with global regulations and manages assigned programs supporting pharmacovigilance operations, from study start-up preparation through closure.

The Senior Manager oversees vendor processes, training, compliance, and CAPA development; ensures submission compliance with business partners, CROs, and global regulatory authorities; and supports inspection readiness and inspections. The role also supports data requests, safety and clinical database reconciliation for serious adverse events, use of metrics to improve productivity and quality, and data readiness for aggregate reports such as DSURs and IDMC listings.

The position collaborates with internal and external partners on case management, aggregate reporting, signal detection, safety-related study documents, and aligned PV and Safety procedures. Key internal partners include Clinical Data Management, Clinical Operations, Clinical Development, and Quality Assurance. The role also trains and mentors staff, develops procedures and tools, and contributes to team members’ performance reviews and professional development plans.

Requirements

• BS/BA degree in a related discipline and a minimum of 10 years of related experience, or an equivalent combination of education and experience.
• Drug Safety and Pharmacovigilance experience, including at least 8 years in Pharmacovigilance Operations.
• Working knowledge of and experience with international regulatory adverse event reporting requirements.
• Proven experience and effectiveness guiding PV vendor staff.
• Extensive knowledge of biotechnology and pharmaceutical sector drivers and practices.
• Excellent knowledge of relevant U.S. and international regulations, guidance, and initiatives governing clinical-trial and post-marketing safety environments.
• Advanced skill and insight in gathering, sorting, and applying information to solve problems.
• Strong organizational and planning capabilities, including management of time, workload, and functional resources.
• Strong verbal and written communication skills, including presenting effectively to internal and external audiences.
• Strong interpersonal skills, including resolving challenges by developing agreed-upon resolutions.
• Ability to lead and manage a functional area, align teams on common goals, and engage internal and external stakeholders.
• Ability to assess workload, trends, tasks, and priorities for cross-functional activities and to plan for alternative methods and contingencies.

Responsibilities

• Lead global ICSR activities to comply with global ICSR regulations.
• Manage assigned programs supporting pharmacovigilance operations, from study start-up preparations through closure, in collaboration with stakeholders.
• Oversee external case management vendor processes, training, compliance, and CAPA development.
• Ensure submission compliance with business partners, CROs, and global regulatory authorities.
• Support inspection readiness and activities during inspections.
• Support general data output and requests for information.
• Ensure reconciliation of safety and clinical databases for serious adverse events.
• Use metrics to assess productivity, identify workflow and quality improvements, and measure the effectiveness of change initiatives.
• Work with PV management and cross-functional team members to ensure PV compliance and inspection readiness.
• Support data readiness for production and submission of aggregate reports, including DSURs and IDMC listings.
• Collaborate with internal and external functions to align case management, aggregate reporting, and signal detection activities.
• Collaborate with clinical teams on preparation and updates of safety-related study documents, including protocols, ICFs, Safety Management Plans, PVA or SDEA, DMP, ECCG plans, SAE reconciliation plans, DTA plans, and monthly data reviews.
• Collaborate with Quality Management to develop or update integrated and aligned PV and Safety SOPs and work instructions.
• Engage with cross-functional partners, including Clinical Data Management, Clinical Operations, Clinical Development, and Quality Assurance.
• Develop procedures, tasks, and tools; train and mentor staff on departmental products, tools, and data sources.
• Plan and execute multiple projects or activities, assess priorities and workload, and develop solutions for cross-functional challenges.
• Engage, influence, and collaborate with stakeholders on cross-functional projects.
• Contribute to team members’ performance reviews and professional development plans.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 11 paid company holidays; eligible employees in specified groups also receive 3 optional holidays.
• Additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs, depending on eligibility.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior