[Remote] Head of Drug Safety and Pharmacovigilance

Note:The job is a remote job and is open to candidates in USA. Alpha-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 lead 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 Alpha-9’s PV strategy, covering early clinical trials through post-marketing readiness• Serve as the senior medical and scientific authority for drug safety, providing expert oversight of adverse event management, benefit-risk assessments, and safety signal evaluation• Build, lead, and mentor a high-performing PV organization, including internal staff and external partners, fostering a culture of compliance, scientific rigor, and patient-centric safety• Oversee PV operations and vendor management, ensuring high-quality case processing, timely reporting, reconciliation, and inspection-ready documentation• Lead 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 eventual NDA/MAA filings)• Integrate PV insights across the company, collaborating with Clinical Operations, Regulatory Affairs, Biostatistics, and Quality to embed safety considerations into trial design and program planning• Ensure compliance with global regulations, including FDA, EMA, ICH, GVP, CIOMS, and TGA, while maintaining inspection-ready PV systems and SOPs• Represent Alpha-9 in regulatory interactions and inspections, providing transparency and scientific credibility• Drive continuous improvement, implementing scalable PV processes, operational metrics, and governance frameworks suitable for a growing biotechSkills• MD or equivalent advanced scientific/medical degree• 10+ years of pharmacovigilance experience, including at least 5 years in senior leadership roles• Proven track 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 related AE monitoring, first-in-human dose escalation, and long-term safety follow-up• Deep knowledge of global PV regulations and inspection readiness requirements• Exceptional leadership, analytical, and communication skills, able to translate complex safety data into actionable insights for internal and regulatory stakeholders• Entrepreneurial, collaborative, and adaptable mindset 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 well experience with radiation-related AE monitoring and familiarity with dosimetryBenefits• Competitive salary• Bonus• Equity• 20 vacation days• 5 sick days• Technology allowance• Commuter reimbursement• Generous retirement savings plans with employer matching• Extended health benefits• Paid holidaysCompany Overview• Alpha-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