Senior Manager (Safety Ops/Safety Scientist)

Bristol Myers Squibb • Princeton, NJ

6d • $149,860 - $181,595

About The Position

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

The Senior Manager oversees external vendor processes, training, compliance, and corrective and preventive action (CAPA) development; ensures submission compliance with business partners, CROs, and global regulatory authorities; and supports inspection readiness and inspections. The role also supports safety data requests, reconciliation of safety and clinical databases for serious adverse events, and data readiness for aggregate reports such as DSURs and IDMC listings. It uses metrics to evaluate productivity, quality, workflow opportunities, and the impact of change initiatives.

The position collaborates with pharmacovigilance management, clinical teams, Quality Management, and internal and external stakeholders. Work includes aligning case management, aggregate reporting, and signal detection; preparing and updating safety-related study documents; and developing or updating integrated PV and Safety SOPs and work instructions. Cross-departmental interactions include Clinical Data Management, Clinical Operations, Clinical Development, and Quality Assurance.

Requirements

• Bachelor of Science or Bachelor of Arts degree in a related discipline and at least 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 guiding pharmacovigilance 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 ability to gather, sort, and apply information to solve problems.
• Strong organizational and planning capabilities, including managing time, workload, and functional resources.
• Ability to lead and manage a functional area and execute objectives that support team and departmental goals.
• Strong verbal and written communication skills, including providing timely updates and presenting effectively to internal and external audiences.
• Strong collaboration, stakeholder engagement, interpersonal, and challenge-resolution skills.
• Ability to develop procedures, tasks, and tools.
• Ability to assess workload, trends, tasks, and priorities proactively across cross-functional activities.
• Ability to plan and execute multiple projects, consider alternative methods and contingency plans, and design solutions to cross-functional challenges.

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 outputs and information requests.
• Ensure reconciliation of safety and clinical databases for serious adverse events.
• Use metrics to assess productivity, identify workflow and quality improvement opportunities, 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 across internal and external functions to align case management, aggregate reporting, and signal detection activities.
• Collaborate with clinical teams to prepare and update safety-related study documents, including protocols, ICFs, Safety Management Plans, PVA or SDEA, DMP, ECCG plan, SAE reconciliation plan, DTA plan, and Monthly Data Review materials.
• Collaborate with Quality Management to develop or update integrated and aligned PV and Safety SOPs and work instructions.
• Engage with Clinical Data Management, Clinical Operations, Clinical Development, Quality Assurance, and other internal and external cross-functional stakeholders.
• Train and mentor staff on departmental products, tools, and data sources; mentor junior team members and contribute to performance reviews and professional development plans.
• Plan and execute multiple projects or activities, assess cross-functional workloads and priorities, and implement solutions that account for broader project impacts.

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 without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt and RayzeBio employees, and employees located in Puerto Rico.
• 11 paid company holidays annually; eligible non-exempt and RayzeBio employees and employees in Puerto Rico also receive 3 optional holidays.
• Depending on eligibility, 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.
• 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