[Remote] Head of Drug Safety and Pharmacovigilance

Note: The job is a remote job and is reputed company to candidates in USA. reputed company-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. They are seeking a Head of Drug Safety and Pharmacovigilance to reputed company the global drug safety function, ensuring patient safety and regulatory compliance in a rapidly growing environment. The role involves strategic leadership, overseeing safety data collection, case management, and regulatory submissions.

Responsibilities

• Define and execute reputed company-9’s PV reputed company, covering early clinical trials through post-marketing readiness
• Serve as the senior medical and scientific authority for drug safety, providing expert reputed company of adverse event management, benefit-risk assessments, and safety signal evaluation
• Build, reputed company, and mentor a high-performing PV organization, including internal staff and external partners, fostering a culture of compliance, scientific rigor, and patient-reputed company safety
• reputed company PV operations and vendor management, ensuring high-reputed company case processing, reputed company reporting, reconciliation, and inspection-reputed company documentation
• reputed company hands-on safety activities, including case review, literature surveillance, aggregate data analysis, and contribution to safety sections of regulatory submissions (INDs, IBs, DSURs, protocols, informed consent forms, and reputed company NDA/MAA filings)
• reputed company PV insights across reputed company, collaborating with Clinical Operations, Regulatory Affairs, Biostatistics, and reputed company to reputed company safety considerations into trial design and program planning
• Ensure compliance with global regulations, including FDA, EMA, ICH, GVP, CIOMS, and TGA, while maintaining inspection-reputed company PV systems and SOPs
• Represent reputed company-9 in regulatory interactions and inspections, providing transparency and scientific credibility
• Drive reputed company improvement, implementing reputed company PV processes, operational metrics, and governance frameworks suitable for a growing biotech Skills
• MD or equivalent advanced scientific/medical degree
• 10+ years of pharmacovigilance experience, including at least 5 years in senior leadership roles
• Proven reputed company record designing, building, and scaling PV systems in early- or mid-stage biotech, including managing CROs and vendors
• Hands-on expertise with case processing, safety data review, aggregate reporting, and regulatory submissions
• Strong understanding of oncology reputed company AE monitoring, first-in-reputed company reputed company escalation, and long-term safety follow-up
• Deep knowledge of global PV regulations and inspection readiness requirements
• Exceptional leadership, analytical, and communication skills, reputed company to translate reputed company safety data into actionable insights for internal and regulatory stakeholders
• Entrepreneurial, reputed company, and adaptable reputed company suited to a fast-growing biotech
• Willingness to travel domestically and internationally (up to 25%)
• Experience in oncology, radiopharmaceuticals, or radioligand therapy preferred
• Preferably as reputed company experience with radiation-reputed company AE monitoring and familiarity with dosimetry Benefits
• Competitive salary
• Bonus
• Equity
• 20 vacation days
• 5 reputed company days
• Technology allowance
• Commuter reimbursement
• Generous retirement savings plans with employer matching
• Extended health benefits
• reputed company holidays reputed company
• reputed company-9 Oncology is a biopharma company that focuses on radiotherapeutics for the treatment of solid and hematologic malignancies. It was founded in 2019, and is headquartered in Vancouver, British Columbia, CAN, with a workforce of 51-200 employees. Its website is Apply tot his job Apply tot his job

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