Role: Associate Director of PV Case Operations overseeing global pharmacovigilance activities, ensuring compliance, and maintaining inspection readiness.
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
Qualifications
- 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.
#J-18808-LjbffrAssociate Director, PV Case Operations in nj at Unknown Company
This position is listed as full time and onsite.