Senior Manager (Safety Ops/Safety Scientist)

Regulatory Toolkit; Princeton (NJ); On-site; USD 150,000 - 182,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Comprehensive benefits

Job summary

RayzeBio in Princeton, NJ seeks a Senior Manager to lead the Global Patient Safety ICSR activities and oversee PV vendor operations, ensuring submission compliance with global regulatory authorities and inspection readiness.

The role collaborates with Clinical Data Management, Clinical Operations, and Quality Assurance to drive PV data readiness for DSURs and aggregate reporting, while supporting risk management initiatives.

Qualifications

• Drug Safety and Pharmacovigilance, 8+ years in PV Operations.
• Knowledge of international AE reporting requirements.
• Proven ability to guide PV vendor staff.

Responsibilities

• Lead global ICSR activities to comply with ICSR regulations.
• Manage PV program(s) and study start-up through closure with stakeholders.
• Oversee external case management vendors, CAPA, and submission readiness.
• Ensure data reconciliation between safety and clinical databases for SAEs.
• Collaborate to prepare safety-related study documents and aggregate reports.

Skills

Global PV leadership

Regulatory compliance

Vendor management

Cross-functional collaboration

Data analysis

Education

BS/BA in related field

Equivalent experience

Job description

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly‑owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

This position provides management role to the oversight of the Global Patient Safety case management, operational oversight of drug safety case management vendor, safety submission compliance, and cross functional collaboration to support risk management and pharmacovigilance activities for the Global Patient Safety department.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Responsible for leading the global ICSR activities to comply with global ICSR regulations.
• Manage and lead the assigned program(s) to support PV operations activities. These include study start up preparations up to closure working with various stakeholders.
• Oversee processes, training and compliance of external case management vendors, CAPA development.
• Provide oversight and ensure submission compliance with business partners, CROs and global regulatory authorities.
• Support Inspection Readiness and During Inspection.
• Support general data output/requests for info.
• Ensure data reconciliation of the safety and clinical databases for Serious Adverse Events.
• Effectively utilize metrics to assess productivity, opportunities for workflow and quality improvement, and to measure effectiveness of change initiatives.
• Work with PV management and other cross functional team members to ensure PV compliance and inspection readiness.
• Support data readiness for the production and submission of aggregate reports (e.g., DSUR, and IDMC listings).
• Collaborate with other internal and external functions to ensure alignment among case management, aggregate reporting, and signal detection activities.
• Collaborate with clinical teams in the preparation of and updates to safety‑related study documents (e.g., Protocols, ICFs, Safety Management Plans, PVA or SDEA, DMP, ECCG plan, SAE Recon Plan, DTA Plan, Monthly Data Review, etc.).
• Collaborate with the Quality Management function to develop or update Standard Operating Procedures and Work Instructions for PV and Safety, which are integrated and fully aligned.
• Significant cross‑departmental interactions with other Rayzebio functions, including Clinical Data Management, Clinical Operations, Clinical Development, and Quality Assurance groups.

SUPERVISORY RESPONSIBILITIES:

• Interactions with internal/external cross functional Team members.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• BS/BA degree in related discipline and a minimum of 10 years of related experience; or,
• Equivalent combination of education and experience.

Work Experience:

• Drug Safety and Pharmacovigilance including at least 8+ years of experience in Pharmacovigilance Operations.
• Working knowledge of and experience with international regulatory Adverse Event Reporting requirements.
• Proven experience and effectiveness at guiding PV vendor staff.

Knowledge, Skills and Abilities:

• Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices.
• Demonstrates and excellent knowledge of relevant US and international regulations, guidance and initiatives governing both clinical trial and post‑marketing safety environments.
• Demonstrates advanced skill and keen insight in gathering, sorting and applying key information to solve problems.
• Demonstrates strong organizational and planning capabilities by managing time, workload, and resources of a function.
• Leads and manages a functional area within a department to execute on team functional objectives that contribute to accomplishing common functional and departmental goals.
• Demonstrates high standards of verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one‑to‑one situations and effectively presents to audiences within and outside Exelixis.
• Fosters collaboration among team members. Encourages teams to align on common goals. Engages internal and external stakeholders to build relationships.
• Strong interpersonal skills and skilled at effectively resolving challenges by developing an agreed upon resolution.
• Develops procedures, tasks, and tools.
• Trains and mentors staff on departmental products, tools, and data sources. Develops and maintains knowledge of cross‑functional products, tools, and data sources. Mentors junior team members. Contributes to performance reviews and professional development plans of team members.
• Capable of proactively assessing workload, trends, tasks, and priorities for cross‑functional activity.
• Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues.
• Designs and implements solutions to address cross functional project level challenges, taking into consideration the broader impact.
• Engages, influences, and collaborates with stakeholders on cross‑functional projects.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Princeton - NJ - US: $149,860 - $181,595

The starting pay range(s) listed above is for full‑time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non‑exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time‑off benefits, including 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 also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly‑owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

R1608008 : Senior Manager (Safety Ops/Safety Scientist)