Senior Manager Safety PV Ops

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 youll 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 impacton our science on our teams and most importantly on patients. Learn more about RayzeBio: a Bristol Myers Squibb company is a dynamic biotechnology company headquartered in San Diego CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team RayzeBio aims to be the global leader in radiopharmaceuticals

RazyeBio Safety PV Ops

SUMMARY/JOB PURPOSE:

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.

• Applies AI to improve team execution and decisionmaking

Work Environment/Physical Demands:

FT/On site and/or Remote work

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical pharmacy dental and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account BMS Living Life Better and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan short- and long-term disability life insurance accident insurance supplemental health insurance business travel protection personal liability protection identity theft benefit legal support and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited with manager approval 11 paid national holidays (not applicable to employees in Phoenix AZ Puerto Rico or Rayzebio employees)

• Phoenix AZ Puerto Rico and Rayzebio Exempt Non-Exempt Hourly Employees: 160 hours annual paid vacation for new hires with manager approval 11 national holidays and 3 optional holidays

Based on eligibility* additional time off for employees may include unlimited paid sick time up to 2 paid volunteer days per year summer hours flexibility leaves of absence for medical personal parental caregiver bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

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. Visit access our complete Equal Employment Opportunity statement.

Candidate Rights

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

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection

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