Associate Director, PV Case Operations
Scorpion Therapeutics
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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
Job description
Role: Associate Director of PV Case Operations overseeing global pharmacovigilance activities, ensuring compliance, and maintaining inspection readiness.
- 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
- Bachelor's degree (advanced degree preferred)
- 10+ years in pharmacovigilance/drug safety
- extensive knowledge of FDA, EU, and ICH PV regulations
- experience managing teams and complex projects
HighValue: pharmacovigilance, drug safety, PV quality, ICSR management, regulatory compliance, audit readiness, global development and marketed products, clinical trial and post-marketing phases, cross-functional collaboration.
WorkSetup: onsite in Warren, NJ; Tarrytown, NY; or Cambridge, MA; approximately 25% travel.
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