Senior Pharmacovigilance Operations Leader

Summit Therapeutics, Inc.; 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. You will oversee outsourced safety operations, vendor governance, and regulatory compliance across clinical and post-market settings, scaling PV capabilities and ensuring inspection readiness.

The ideal candidate has extensive PV experience, cross-functional leadership, and data-driven problem solving. Role requires collaboration with Clinical Operations, Regulatory, and Quality teams, and

Qualifications

• Degree in Life Sciences, Pharmacy, Nursing or related field.
• Minimum 10+ years of PV experience in biotech, pharma or CRO.
• Experience with vendor oversight, governance and PVAs/SDEAs.

Responsibilities

• Oversee ICSR collection, processing, reconciliation and reporting to meet timelines.
• Oversee PV vendor activities, KPIs, and inspection readiness.
• Ensure global PV regulatory compliance and timely submissions.
• Develop and maintain PV SOPs, SMPs and PVAs/SDEAs.
• Collaborate with cross-functional teams to ensure safety data exchange and reporting.

Skills

Vendor governance

PV operations

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Tools

Argus

ARISg

Vault Safety

Job description

Summit Therapeutics Inc. is seeking an experienced Associate Director of Pharmacovigilance Operations. You will oversee outsourced safety operations, vendor governance, and regulatory compliance across clinical and post-market settings, scaling PV capabilities and ensuring inspection readiness.

The ideal candidate has extensive PV experience, cross-functional leadership, and data-driven problem solving. Role requires collaboration with Clinical Operations, Regulatory, and Quality teams, and