Pharmacovigilance Operations Manager

Scorpion Therapeutics; United States; Remote; USD 120,000 - 190,000; Full time

Job summary

Scorpion Therapeutics, based in the United States, is seeking a PV Operations Manager to oversee global pharmacovigilance activities for oncology programs, focusing on clinical trial safety and post-market surveillance.

You will manage external safety vendors, ensure PV system compliance, support audits, and collaborate with Clinical Ops, Regulatory, and QA to optimize safety data flow and risk management. This role is fully remote with quarterly travel to corporate offices.

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum 5 years PV operations experience.
• At least 4 years in oncology (NMIBC or GU cancers highly preferred).
• Experience leading PV teams or vendor management for at least 3 years.
• Strong knowledge of global PV regulations (ICH, FDA, EMA).

Responsibilities

• Oversee global pharmacovigilance activities for oncology programs.
• Manage external safety vendors and PV system compliance.
• Support audit and inspection readiness.
• Collaborate with Clinical Ops, Regulatory, QA to facilitate safety data flow and risk management.
• Drive process optimization, documentation, and PV process training.

Skills

Leadership

Vendor management

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's in life sciences or related field

Job description

PV Operations Manager

overseeing global pharmacovigilance activities for CG Oncology, focusing on clinical trial safety and post-market surveillance.

Responsibilities

• managing external safety vendors
• ensuring PV system compliance
• supporting audit and inspection readiness
• collaborating with Clinical Ops, Regulatory, QA, and other teams to facilitate safety data flow and risk management
• process optimization
• documentation
• training related to PV processes

Qualifications

• Bachelor's in life sciences or related field
• minimum 5 years of PV operations experience
• at least 4 years in oncology (NMIBC or GU cancers highly preferred)
• Experience leading PV teams or vendor management for at least 3 years
• strong knowledge of global PV regulations (e.g., ICH, FDA, EMA)

Preferred

• clinical bedside healthcare background (RN, NP, PA)
• oncology-specific PV expertise
• experience in GxP-regulated environments

High-value biopharma specifics

• focus on oncology, bladder cancer, immunotherapies, and clinical safety operations

Work setup

Fully remote with quarterly travel to corporate offices.