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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.

The Executive Director, Head of Pharmacovigilance - Safety Science, is responsible for overseeing all aspects of product safety across clinical development and post-marketing surveillance. This key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards, and drives the strategy and execution of safety science to protect patient health and optimize product benefit-risk profiles. The ED works cross-functionally with clinical, regulatory, medical affairs, quality, and commercial teams to support the safe use of products globally.

Responsibilities:

Pharmacovigilance Strategy and Oversight

·Develop and lead the global pharmacovigilance strategy to ensure proactive risk management and compliance with local and international PV regulations (e.g., FDA, EMA, ICH).

·Oversee end-to-end PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment.

·Establish and maintain 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, aggregate reporting, and product safety strategy.

·Lead the detection, evaluation, and management of safety signals, collaborating with cross-functional teams to implement risk minimization strategies and communicate potential safety concerns.

·Oversee safety aspects of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries.

Cross-Functional Leadership and Stakeholder Engagement

·Partner with clinical, regulatory, and medical affairs teams to integrate safety insights into product development, clinical trial design, and labeling strategies.

·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.

Team Leadership and Development

·Lead and mentor a high-performing pharmacovigilance and safety science team, fostering a culture of collaboration, accountability, and scientific excellence.

·Define and implement processes for continuous improvement within safety science, and risk management.

Education and Experience

·MD, PharmD, PhD, or other advanced degree in a relevant field.

·10+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry,

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