Drug Safety Physician

Bristol Myers Squibb•Princeton, NJ

About The Position

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 RayzeBio Safety MD Summary/Job Purpose: Safety MD lead/co-lead roles/responsibilities on proactive safety surveillance/monitoring of safety signals/risks/issues and providing safety/PV expertise including mentoring in interactions with cross-functional groups.

Requirements

MD or equivalent (MBBS etc)
10+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry.
10+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry.
Full knowledge/awareness of existing/current global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH
Demonstrable understanding of clinical development, post-marketing safety, and regulatory submissions
Demonstrated expertise in signal detection, risk management, benefit-risk assessment, and aggregate safety reporting.
Experience interacting with global regulatory authorities and scientific advisory bodies
NDA/MAA/JNDA submission experience preferably
Strong leadership and communication skills
Proven ability to work effectively in a matrixed, cross-functional environment.
Demonstrated commitment to patient safety and ethics in medical practice.
Demonstrated commitment to patient safety and ethics in medical practice.
Demonstrated commitment to patient safety and ethics in medical practice.

Nice To Haves

Radiopharmaceutical experience
Oncology experience

Responsibilities

Safety lead/co-lead contribution to the global pharmacovigilance strategy to ensure proactive safety risk and surveillance, safety management and compliance with local and international PV regulations (e.g., FDA, EMA, ICH).
Safety lead/co-lead contribution in establishing and maintaining robust safety governance structures and standard operating procedures, ensuring alignment with company objectives and industry best practices.
Ensure collaboration with BMS safety and clinical development leadership Safety Science and Risk Management
Direct safety evaluation and risk management for clinical development and post-marketing products, including benefit-risk assessments and product safety strategy.
Provide safety lead/co-lead representation via the Safety Management Team/Safety Management Committee in the proactive detection, evaluation, management and of safety signals/risks, collaborating with cross functional teams to implement risk minimization strategies and communicate potential safety concerns including important new safety information/finding as well as those meeting criteria for unanticipated problem (UAP).
Represent safety science as lead/co-lead safety MD for health authority interactions and drive safety related content of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries.
Contribute to understanding and managing the AE profile of products in development and ensuring appropriate safety management in all phases of clinical trials
Lead the strategy and review of safety modules and risk management plans in regulatory filings
Mentoring cross functional colleagues, direct reports, safety colleagues on PV key concepts/principles
Performing daily ICSR/SAE case reviews through existing SAE safety databases.
Contribute to the development of risk/benefit analyses in regulatory filings and HTA submissions
Partner with clinical, regulatory, and medical affairs teams to integrate safety insights into product development, clinical trial design, and labeling strategies.
Providing safety lead/co lead contribution to safety sections of documents during protocol reviews, IB and DSUR updates, ICFs or Reference Safety Language (RSLs), CSRs, etc.
Actively participate in Data Review Meetings/Activities on the RYZ Investigational Products.
Active participation as safety lead MD in study team meetings (SET meetings) for the respective RYZ project teams, safety knowledge group consultations, etc.
Act as the key PV representative for interactions with global regulatory authorities and stakeholders, advocating for patient safety
Engage with external experts, scientific bodies, and industry groups to stay updated on evolving PV practices and enhance the organization’s safety profile.
Providing safety MD lead support/co-lead in Regulatory Agencies’ PV audits, FDA GPV or GCP inspections, etc
Define and implement processes for continuous improvement within safety science, and risk management.
Back up Safety MD for PV Head

Benefits

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.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume