PV Strategy Director: Global Oversight & Innovation

Scorpion Therapeutics; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics in Cambridge, MA seeks a senior pharmacovigilance leader to own end-to-end PV processes, aligning cross-functional teams with regulatory requirements and inspection readiness.

Role emphasizes strategic oversight, risk identification, and continuous process improvement through technology-enabled capabilities, with a focus on collaboration across QA, Regulatory, and Development teams.

Qualifications

• Senior leadership experience managing matrix teams and cross-functional partnerships.
• 10+ years in pharmaceutical industry with focus on drug safety and pharmacovigilance.
• Excellent planning, execution, and communication skills; results-driven.

Responsibilities

• Own end-to-end PV process strategy, direction, and implementation.
• Act as central orchestrator for PV processes and drive alignment and accountability.
• Lead cross-functional governance and operational excellence (roles, forums, decisions).
• Design, document, implement, manage, and oversee designated E2E PV processes.
• Develop and maintain procedural documents, templates, and training materials.
• Provide PV oversight by identifying risks, trends, and gaps; escalate and mitigate.
• Serve as main contact for Quality Events, CAPAs, and Change Controls; support audits/inspections.
• Contribute to impact assessments for changes in PV regulatory requirements; implement updates.
• Champion tech/AI-enabled capabilities to maintain inspection readiness.
• Provide backup support for other PV processes as needed.

Skills

Strategic leadership

Cross-functional collaboration

Negotiation & influence

Planning & execution

Communication

Education

Bachelor’s degree or international equivalent

Life Sciences preferred

Job description

Scorpion Therapeutics in Cambridge, MA seeks a senior pharmacovigilance leader to own end-to-end PV processes, aligning cross-functional teams with regulatory requirements and inspection readiness.

Role emphasizes strategic oversight, risk identification, and continuous process improvement through technology-enabled capabilities, with a focus on collaboration across QA, Regulatory, and Development teams.