JOB TITLE: Associate Director (AD) – Case Management and Strategic Partnerships

REPORTS TO: Vice President, Pharmacovigilance

LOCATION: Boston, MA                                                                  

DATE PREPARED: October 21, 2026

JOB SUMMARY: 

The Associate Director – Case Management and Strategic Partnerships provides oversight and operational leadership for outsourced ICSR processing, clinical trial/post market safety operations, and PV alliance management within Global PV Operations. The role leads clinical trial/post market case management, vendor oversight, aligning vendor activities with global PV requirements, study-specific safety reporting obligations, internal procedures, quality standards, contractual obligations, and processing timelines. Through evaluation of vendor KPIs, operational metrics, and compliance trends, the Associate Director identifies and escalates risks, addresses deficiencies, supports CAPA, and drives sustainable process improvements. The role partners with cross-functional stakeholders and PV leadership to resolve operational and case-related issues, support data integrity, high-quality safety deliverables, strengthens the PV quality system, and maintain audit/inspection readiness. Responsibilities also include technical guidance, governance of PV procedures, and supporting change management and training, participation in audits/inspections, and development and maintenance of PV agreements with business and license partners.

PRINCIPAL DUTIES:   

·        Lead clinical trial/post market case management vendor oversight within Global PV Operations, ensuring outsourced ICSR processing activities meet regulatory requirements, established quality standards, contractual obligations, and processing timelines; escalate risks as needed.

·        Oversee external pharmacovigilance vendors, evaluating key performance indicators (KPIs), operational metrics, and compliance performance to identify risks, address deficiencies, and drive continuous improvement.

·        Provide strategic oversight of clinical trial/post market PV operations, ensuring vendor activities align with global PV requirements, internal procedures, and study-specific safety reporting obligations.

·        Provide operational leadership and technical guidance to support consistent execution, timely safety reporting, and high-quality PV deliverables.

·        Partner with internal and external cross-functional stakeholders and vendors to strengthen compliance, resolve case issues and operational challenges, ensure source-to-database consistency, and maintain inspection-ready documentation.

·        Participate in PV audits/inspections and internal quality activities by providing case documentation and responses to safety-related requests.

·        Maintain compliance with global PV regulatory requirements and guidance (e.g., FDA/EMA/MHRA) and internal SOPs/work instructions; track and trend compliance findings as assigned and support corrective and preventive actions (CAPA) where applicable.

·        Identify process gaps and operational inefficiencies, collaborating with cross-functional stakeholders to develop and implement sustainable improvements.

·        Collaborate with the Director, PV Operations and Project Management and the VP, Pharmacovigilance, to build and maintain the PV quality system (e.g., gap assessments; departmental policies/SOPs/procedures; and job-related training).

·        Provide strategic direction and governance for PV SOPs, work instructions, templates, and policies, including processes and procedures governing outsourced safety activities; align their development, implementation, maintenance, and refinement with regulatory requirements and operational priorities, and oversee supporting change management and training.

·        Develop and maintain PV agreements with business and license partners. • Performs other duties as assigned. 

BASIC QUALIFICATIONS:

·        U.S.-based.

·        Bachelor’s degree in life science or healthcare-related field (e.g., biology, pharmacy, nursing).

·        8+ years of progressively responsible pharmacovigilance experience in the biotechnology or pharmaceutical industry, encompassing clinical development and post-marketing safety operations, ICSR compliance, and increasing operational leadership responsibility.

·        5+ years leading oversight of outsourced PV vendors/service providers, including clinical trial case management, KPI and operational metric evaluation, contractual performance monitoring, risk escalation, and remediation of compliance deficiencies.

·        Demonstrated experience leading the development, implementation, and maintenance of PV agreements with business and license partners, including definition of safety responsibilities, reporting obligations, and operational interfaces.

·        Experience with Argus Safety and the use of safety database outputs to oversee ICSR processing, reporting compliance, and vendor performance.

·        In-depth knowledge of global PV regulations and guidance (e.g., FDA/EMA/MHRA), with demonstrated ability to apply clinical trial and post-marketing safety reporting requirements, data integrity principles, and GxP quality standards to outsourced safety operations.

·        Demonstrated ability to translate PV requirements and operational priorities into effective SOPs, work instructions, and governance processes, and to lead associated change management, training, and sustainable process improvements.

·        Experience supporting PV audits/inspections, evaluating compliance trends and operational risks, and guiding root cause analysis, CAPA, and remediation activities within a PV quality system.

·        Demonstrated cross-functional leadership and ability to influence internal stakeholders and external partners without direct reporting authority; strong judgment, technical communication, and prioritization skills to resolve complex issues and communicate risks and recommendations to PV leadership.

PREFERRED QUALIFICATIONS:

·        Experience establishing or enhancing global PV vendor governance frameworks, including risk based oversight, performance scorecards, escalation pathways, and governance forums across multiple studies or products.

·        Experience leading cross-functional PV transformation initiatives, such as vendor transitions, operating model enhancements, or technology-enabled process improvements, with demonstrated improvements in compliance, efficiency, or reporting timeliness.

·        Advanced proficiency in Excel and experience with reporting or visualization tools to integrate vendor KPIs, compliance trends, and operational risk indicators into actionable management dashboards.

·        Experience representing PV Operations in senior-level vendor or alliance governance forums, presenting performance and risk assessments, and building stakeholder alignment on remediation priorities and operational decisions..

This job description is intended to describe the general nature and level of the work being performed by employees in the position.  It is not intended to be a complete list of all responsibilities, duties, and skills for the position.  The Company reserves the right at all times, in its sole discretion, to add or subtract duties and responsibilities, as it deems necessary.  

About AVEO

AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.