Senior DSPV Manager - Rare Disease Safety (Remote)

Travere Therapeutics; Columbus (OH); A distancia; USD 132.000 - 172.000; Jornada completa

Descripción de la vacante

Travere Therapeutics seeks a Senior Manager, Drug Safety & Pharmacovigilance to supervise day-to-day PV operations and medical review across DSPV and Safety Science. You will oversee ICSR processing, regulatory reporting, vendor oversight, and CAPA-driven quality improvements.

The role includes medical review of safety data, signal detection, and preparation of safety reports while ensuring compliance with global regulations and company policies. Remote-friendly in the San Diego area.

Formación

• Bachelor's degree in life sciences or related field.
• 6+ years of Drug Safety/Pharmacovigilance experience in pharma/biotech/CRO.
• Experience with ICSR processing and regulatory reporting compliance.

Responsabilidades

• Manage day-to-day pharmacovigilance operations (internal and PV service providers).
• Monitor regulatory reporting timelines for expedited safety reports.
• Quality review of ICSRs and safety documents for regulatory compliance.
• Oversee PV vendor performance and KPIs; drive issue resolution.
• Perform safety data reconciliations including SAE reconciliation with clinical databases.
• Support development of safety-related plans and safety data exchange agreements.
• Lead investigations of PV deviations and CAPA implementation.
• Assist in inspections and audit readiness for pharmacovigilance.

Conocimientos

ICSR management

Vendor oversight

Regulatory reporting

Medical review

Safety data reconciliation

Cross-functional teamwork

Educación

Bachelor's degree in life sciences

Healthcare professional degree preferred

Herramientas

ARGUS

ARISg

MedDRA

WHO Drug coding

Descripción del empleo

Travere Therapeutics seeks a Senior Manager, Drug Safety & Pharmacovigilance to supervise day-to-day PV operations and medical review across DSPV and Safety Science. You will oversee ICSR processing, regulatory reporting, vendor oversight, and CAPA-driven quality improvements.

The role includes medical review of safety data, signal detection, and preparation of safety reports while ensuring compliance with global regulations and company policies. Remote-friendly in the San Diego area.