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, 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/

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 regu