PV Operations Director: Scale Post-Market Safety

Scorpion Therapeutics; Boston (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director/Director of Pharmacovigilance Operations to scale PV infrastructure as the company transitions from clinical to commercial stage. The role focuses on post-market safety systems, governance, and data management.

You will lead cross-functional collaboration with Clinical Development, Regulatory, Medical Affairs, and Quality, oversee vendor performance, and ensure inspection readiness while authoring safety documentation.

Qualifications

• 8+ years in PV with biotech/pharma.
• Experience supporting clinical-to-commercial transition.
• Deep knowledge of global PV regulations (FDA, EMA, ICH, GVP).

Responsibilities

• Lead PV system design, implementation, and ongoing maintenance for post-market safety.
• Support regulatory submissions (NDA/MAA).
• Manage vendor performance and oversight.
• Oversee PV compliance, audit readiness, and inspection preparation.
• Collaborate with Clinical Development, Regulatory, Medical Affairs, and Quality.
• Author safety documentation and establish PV governance.
• Optimize safety databases and coordinate safety data exchange agreements.

Skills

PV system design

Regulatory submissions

Vendor management

Cross-functional collaboration

Safety documentation

Education

Bachelor's in nursing, pharmacy, or related healthcare field

Master’s degree preferred

Tools

Argus/ArisG

Medidata Rave

Job description

Scorpion Therapeutics is seeking an Associate Director/Director of Pharmacovigilance Operations to scale PV infrastructure as the company transitions from clinical to commercial stage. The role focuses on post-market safety systems, governance, and data management.

You will lead cross-functional collaboration with Clinical Development, Regulatory, Medical Affairs, and Quality, oversee vendor performance, and ensure inspection readiness while authoring safety documentation.