Global PV Operations Leader — Associate Director

Socket.dev; Palo Alto (CA); On-site; USD 174,000 - 205,000; Full time

Job summary

Summit Therapeutics Inc. is seeking an experienced Associate Director of Pharmacovigilance Operations to lead global PV ops, oversight of outsourced safety operations, and vendor governance across clinical and post-market programs.

The role ensures inspection readiness, regulatory compliance, and scalable PV capabilities, reporting to the Executive Director PV Ops and Compliance. Responsibilities include SOPs, safety data exchanges, and cross-functional collaboration.

Qualifications

• Degree in Life Sciences, Pharmacy, Nursing or related field.
• 10+ years of PV experience in biotech, pharma or CRO.
• Hands-on vendor oversight and governance experience.
• Experience with safety databases (Argus, ARISg, Vault).
• Knowledge of regulatory PV requirements (FDA, EMA, MHRA).
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Oversee ICSR collection, processing, reconciliation, and reporting to meet global standards.
• Manage PV vendor activities, KPIs, and maintain inspection readiness.
• Ensure global PV compliance and timely submissions and reporting.
• Develop PV SOPs, work instructions and guidance documents.
• Develop and maintain SMPs, PVAs/SDEAs with partners.
• Coordinate safety data exchanges with CROs and partners.
• Oversee PV database configuration and maintenance.
• Support PV audits and inspections as SME.
• Lead CAPA and deviation management related to safety reporting.
• Collaborate with Clinical Operations, Regulatory and QA to ensure safety submissions.
• Represent PV in governance forums and cross-functional initiatives.
• Assist in budget, MSAs, SOWs and vendor payments.

Skills

PV Operations

Vendor Governance

ICSR Processing

Regulatory Compliance

Cross-functional Collaboration

Quality Assurance

Problem Solving

Education

Life Sciences/Pharmacy/Nursing

Tools

Argus

ARISg

Vault Safety

Job description

Summit Therapeutics Inc. is seeking an experienced Associate Director of Pharmacovigilance Operations to lead global PV ops, oversight of outsourced safety operations, and vendor governance across clinical and post-market programs.

The role ensures inspection readiness, regulatory compliance, and scalable PV capabilities, reporting to the Executive Director PV Ops and Compliance. Responsibilities include SOPs, safety data exchanges, and cross-functional collaboration.