Director, Pharmacovigilance Operations

Scorpion Therapeutics; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

Neurogene seeks a Lead Global Pharmacovigilance professional to manage PV operations for its clinical and future gene therapy products. You will ensure regulatory compliance, safety governance, and inspection readiness, guiding PV strategy across the organization.

The role requires 10+ years in PV within biotech/pharma contexts, with 5+ years in leadership, and strong knowledge of FDA/EMA/ICH/GVP. Remote with travel may be involved, and US licensure is preferred.

Qualifications

• Bachelor's degree in nursing, pharmacy, or related life sciences.
• 10+ years PV experience in biotech/pharma/CRO settings, with 5+ years in leadership.
• Strong knowledge of global PV regulations (FDA, EMA, ICH, GVP).
• Experience managing PV systems (Argus, ARISg, Veeva).
• US licensure preferred.

Responsibilities

• Lead global pharmacovigilance operations for clinical and future commercial gene therapy products; ensure compliance and operational efficiency.
• Develop PV strategy, oversee vendor management, safety system governance, aggregate reporting, and inspection readiness.
• Collaborate with cross-functional teams (Regulatory, Medical, Clinical, Quality).
• Support regulatory submissions, safety signal detection, and risk management; drive process standardization and continuous improvement.

Skills

PV leadership

Regulatory knowledge

Vendor oversight

Education

Bachelor's degree in nursing, pharmacy, or related life sciences

Tools

Argus

ARISg

Veeva

Job description

Role:

Lead global pharmacovigilance operations for Neurogene's clinical and future commercial gene therapy products, ensuring compliance and operational efficiency.

Responsibilities:

• develop PV strategy, oversee vendor management, safety system governance, aggregate reporting, and inspection readiness
• collaborate with cross-functional teams (Regulatory, Medical, Clinical, Quality)
• support regulatory submissions, safety signal detection, and risk management
• drive process standardization and continuous improvement

Requirements:

• Bachelor's degree in nursing, pharmacy, or related life sciences;
• 10+ years PV experience in biotech/pharma/CRO settings, with 5+ years in leadership;
• strong knowledge of global PV regulations (FDA, EMA, ICH, GVP);
• experience managing PV systems (Argus, ARISg, Veeva);
• vendor oversight and inspection support skills;
• US licensure preferred.

High-Value:

biopharma, gene therapy modalities, clinical development (pre-IND to post-market), safety management, vendor governance, regulatory inspection readiness.

Work setup:

remote with some travel.