Exec Dir Pharmacovigilance Operations

About the position 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.

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

Requirements

• 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
• Demonstrated ability to manage priorities, meet deadlines, and drive results in a a fast-paced environment
• High attention to detail with a strong focus on quality and compliance
• Effective leadership demonstrated through initiative, adaptability and innovative thinking
• Ability to work both independently and within a matrixed team environment
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset

Benefits

• medical
• dental
• vision
• basic life and AD&D insurance
• short-term and long-term disability insurance
• flexible spending accounts
• health savings accounts
• voluntary insurance programs, including voluntary life, AD&D accident, and critical illness
• 401(k) plan
• 10 hours of paid vacation time every month
• 1 hour of paid sick leave for every 30 hours worked
• 17 paid holidays each calendar year, including a winter closure