Director, Global PV Case Operations

Scorpion Therapeutics

New Jersey

On-site

USD 170,000 - 210,000

Full time

4 days ago

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Job summary

Scorpion Therapeutics is seeking an Associate Director of PV Case Operations to oversee global pharmacovigilance activities, ensure ongoing compliance, and maintain readiness for inspections. You will lead ICSR processing and quality reviews, shaping quality frameworks and CAPA actions to drive continuous improvement.

The role requires 10+ years in pharmacovigilance/drug safety, deep regulatory knowledge, and proven leadership of cross-functional teams and complex projects within a global

Qualifications

Bachelor's degree in life sciences; advanced degree preferred.
10+ years in pharmacovigilance/drug safety.
Extensive knowledge of FDA, EU, and ICH PV regulations.
Experience leading teams and complex projects.

Responsibilities

manage case processing deliverables
oversee ICSR quality review
implement quality frameworks
lead root cause analyses
drive CAPA actions
monitor operational metrics and vendor performance
support audits and inspections

Education

Bachelor's degree in life sciences

Job description

The role requires 10+ years in pharmacovigilance/drug safety, deep regulatory knowledge, and proven leadership of cross-functional teams and complex projects within a global

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