Exec Dir Pharmacovigilance Operations

About the role

Avenzo Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation oncology therapies. The Executive Director, Pharmacovigilance Operations will lead global pharmacovigilance operations, ensuring compliant, high-quality safety reporting and processes across clinical programs.

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 matters, 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

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
• Demonstrated ability to manage priorities, meet deadlines, and drive results in 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
• 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

Preferred Qualifications

• Experience in oncology research and development
• Knowledge of oncology-specific pharmacovigilance requirements
• Experience with regulatory submissions and inspections

Benefits

The salary range for this position is $303,000 to $328,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the industry, education, and skills and certifications.

Additional benefits include:

• Group healthcare plans that offer medical, dental, vision, and 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 and 1 hour of paid sick leave for every 30 hours worked
• 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies

Pay

$303,000 to $328,000 per year

Schedule

Full-time