Exec Dir Pharmacovigilance Operations
Job Location:
San Diego, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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
- Bachelors 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
- This position requires periodic/regular travel including up to 15% of work time which may include overnight travel
Physical Demands and Work Environment
Physical Demands:
- Constant or continuous use of a computer keyboard monitor and mouse to perform a variety of tasks
- Constant or frequent sitting standing or walking
- May lift and/or move objects of various weights
Work Environment:
- Home office; expected to travel to and work from the Companys headquarters in San Diego from time to time
- On-site requirement (Monday through Thursday)
- Noise level in the work environment is usually moderate
- Fast-paced time sensitive environment with frequently changing priorities
- Handle multiple projects simultaneously
Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.
Salary Range
The salary range for this position is $303000 to $328000 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.
Benefits
Provided they meet all eligibility requirements under the applicable plan documents employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical dental vision and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance flexible spending accounts health savings accounts and voluntary insurance programs including voluntary life AD&D accident and critical illness. Employees will also be able to enroll in the Companys 401(k) addition employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year including a winter closure subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies which may be amended from time to time.
Other Compensation
The hired candidate will be eligible to receive an annual discretionary bonus and an equity award subject to the terms of the applicable employment agreement plan documents and Company policies.
The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies.
Applications for this position are anticipated to close on July 312026. For more information about this posting please contact.
Equal Employment Opportunity
Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individuals actual or perceived protected characteristic or characteristics or any combination of protected characteristics including race (including traits associated with race such as hair texture and protective hairstyles including braids locks and twists) ethnicity religion religious creed (including religious dress and grooming practices) color sex (including childbirth breast feeding and related medical conditions) gender gender identity or expression sexual orientation national origin ancestry citizenship status uniformed service member and veteran status marital status pregnancy age (40 and over) protected medical condition (including cancer and genetic conditions) genetic information disability (mental and physical) reproductive health decision-making medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act) the employee or their family members status as a victim of a qualifying act of violence political activity or affiliation use of cannabis off the job and away from the workplace association with an individual who has or is perceived to have a protected characteristic or characteristics or any combination of protected characteristics or any other protected status in accordance with all applicable federal state and local laws.
Notice to Search Firms/Third Party Agencies
Avenzo does not accept unsolicited resumes from recruiters employment agencies or search firms without a valid executed search agreement in place.
