Director, Pharmacovigilance Safety Operations

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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 Director of Pharmacovigilance Safety Operations will be responsible for overseeing and managing the pharmacovigilance activities to ensure the safety of our products and compliance with regulatory requirements. This role involves working closely with clinical science, clinical operations and regulatory affairs to ensure accurate and timely reporting of adverse events, and implementing effective risk management strategies. This role requires supporting NDA filing, inspection and product launches

Responsibilities

• Safety Surveillance: Oversee the collection, assessment, and reporting of adverse events and other safety data from clinical trials and post-marketing sources. Oversee CROs and vendor management of case processing and ensure timely review and reporting of AEs, SAEs, SUSARs etc

• Quality and compliance: Support safety database processes and transfers to ensure the integrity of the safety database

• Regulatory Compliance: Ensure compliance with global pharmacovigilance regulations and guidelines, including timely submission of safety reports to regulatory authorities. Support NDAs and health authority, third party inspections.

• Risk Management: Develop and implement risk management plans, including signal detection, risk assessment, and risk minimization activities.

• Stakeholder Collaboration: Collaborate with internal and external stakeholders, including regulatory authorities, healthcare professionals and parent company to ensure effective communication and management of safety issues. Oversee  business partner safety operations requirements e.g. safety data exchange, pharmacovigilance agreements.

• Process Improvement: Continuously evaluate and improve pharmacovigilance processes and systems to enhance efficiency and effectiveness. Manage safety CROs and vendors to ensure quality services, meeting compliance and cost efficient processes.

• Documentation and Reporting: Ensure accurate and comprehensive documentation of safety data and prepare periodic safety update reports (PSURs), development safety update reports (DSURs), and other required regulatory submissions.

• Training and Development: Provide training to internal teams and external partners on pharmacovigilance practices and regulatory requirements. W

Qualifications

• BS degree in a scientific or healthcare-related field with 12 years of experience in pharmacovigilance and safety operations OR MS degree in a scientific or healthcare-related field with 10 years of experience in pharmacovigilance and safety operations (MD, PharmD or PhD is preferred

• Minimum of 10 years of experience in pharmacovigilance and safety operations

• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, GVP, FDA, EMA).

• Proven track record of successful collaboration with regulatory authorities and other stakeholders.

• Experience in safety operations support to NDA filing and product launches.

• Excellent leadership, communication, and interpersonal skills.

• Strong analytical and problem-solving abilities.

• Ability to work effectively in a fast-paced, dynamic environment.

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