Exec Dir Pharmacovigilance Operations

**Job Title:** Executive Director, Pharmacovigilance Operations **Location:** San Diego or Remote U.S. **Job Type:** Full-Time **Who We Are** Avenzo Therapeutics, Inc. (“Avenzo” or “Company”) is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, Inc., respectively). Our team is passionate about and committed to advancing a pipeline of potentially differentiated targeted oncology programs that make a difference in the lives of people with cancer. The Company is headquartered in San Diego, California. **Position Summary** Reporting to the Vice President Clinical Development, the Executive Director, Pharmacovigilance Operations will be responsible for leading, developing and overseeing global pharmacovigilance (PV) operations across all clinical programs at Avenzo Therapeutics. This role provides end-to-end operational oversight of the pharmacovigilance function, including vendor strategy, systems, quality and compliance, ensuring high safety processes and reporting alignment with global regulatory requirements and internal standards. **Essential Job Functions and Responsibilities** - Lead global PV operations, ensuring compliant, high-quality safety reporting and processes across clinical programs - Provide end-to-end oversight for the PV operating model, including vendor management, governance forums (e.g., Safety Management Committee (SMC)) and safety systems - Oversee adverse event case processing Individual Case Safety Report (ICSRs) and aggregate reporting (e.g., Development Safety Update Report (DSUR)) and safety data exchange, ensuring accuracy, quality and adherence to timelines and agreements - Partner with Clinical Leads and Medical Monitors to support medical review and reporting of adverse event assessment, and case management activities - Serve as the primary liaison with internal stakeholders and external partners on PV related matter, including safety data exchange and compliance with PV agreements - Communicate with partner companies, vendors, and internal groups regarding the processing and timely exchange of safety reports and ensuring compliance with partner pharmacovigilance agreements - Develop and update drug safety forms and templates, ensuring harmonization with clinical operation functions during study start-up and conduct of clinical studies - Manage Safety and PV vendor relationships, execution of responsibilities, and ensuring compliance with safety data processing and submission activities - Ensure effective serious adverse event (SAE) reconciliation between clinical and safety databases - Develop and maintain safety and PV process improvements, tools, systems, and procedures - Contribute to the development and maintenance of key safety documents, including core data sheets, investigator brochures, labeling, and Risk Management Plans (RMPs) - Support regulatory inspections and internal audits, including responses to findings - Lead and develop assigned staff, fostering a high-performing and collaborative team environment - Collaborate cross-functionally across development and other functional areas to support integrated program execution **Preferred Qualifications** - Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, PhD) with 12+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience - Deep understanding of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH) - Strong knowledge of Good Pharmacovigilance Practices (GVP), GCP, clinical trial methodology, and medical terminology. - Proficiency with safety databases (e.g., Argus), regulatory regulations, and MedDRA coding standards - Strong project management, analytical, and problem-solving skills with a strategic mindset - Demon…