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Director, Pharmacovigilance Safety Operations - San Diego California
Company: Bristol-Myers Squibb
Location: San Diego, California
Posted On: 05/09/2025
Director, Pharmacovigilance Safety OperationsApply locations San Diego - RayzeBio - CA time type Full time posted on Posted 2 Days Ago job requisition id R1590914Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.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.Key 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.Qualifications
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