[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 reputed company 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 Apply To this Job