Associate Director, Pharmacovigilance Operations

Scorpion Therapeutics; United States; Remote; USD 150,000 - 190,000; Full time

Job summary

CG Oncology seeks an Associate Director, Pharmacovigilance Operations to oversee global PV activities for its bladder cancer therapies. This leadership role drives safety governance, PV system management, and regulatory readiness across trials and post‑marketing activities.

You will collaborate across Clinical Development, Regulatory, Medical Affairs, Quality, IT, and external PV vendors, ensuring GxP compliance, safety data integrity, and timely regulatory submissions while working fully

Qualifications

• Bachelor's in Life Sciences or healthcare field.
• 10+ years in pharmacovigilance, drug safety, or clinical safety.
• 5+ years in PV leadership, vendor oversight, and regulatory compliance; oncology experience preferred.
• Involvement with oncology modalities and regulatory submissions (BLA/NDA) is a plus.

Responsibilities

• Oversee global PV operations for oncology therapies.
• Ensure compliance with GxP standards and regulatory requirements.
• Manage vendor relationships and inspection readiness.
• Support safety data integrity and regulatory submissions.

Skills

PV leadership

Vendor oversight

Regulatory compliance

GxP standards

Oncology experience

Clinical safety

BLA/NDA support

Education

Bachelor's degree in Life Sciences

Tools

PV systems

Job description

Role

Associate Director, Pharmacovigilance Operations, overseeing global PV activities for CG Oncology's bladder cancer therapies.

Responsibilities

Responsibilities include managing PV operations, ensuring compliance with GxP standards, overseeing vendor relationships, maintaining inspection readiness, and supporting safety data integrity and regulatory submissions. Key focus areas involve clinical trial and post-marketing safety activities, PV system management, and safety governance.

Requirements

Requirements: Bachelor's in Life Sciences or healthcare; 10+ years in PV, drug safety, or clinical safety within biotech, pharma, or CROs; 5+ years in PV leadership, vendor oversight, and regulatory compliance; oncology experience preferred, including BLA/NDA support, safety, and PV system expertise. High-value specifics include oncology modalities (immuno-oncology, intravesical therapy), clinical and post-marketing phases, and regulatory preparedness.

Collaboration

Collaboration spans Clinical Development, Regulatory, Medical Affairs, Quality, IT, and external PV vendors.

Location

Fully remote; no travel specified.