Senior DSPV Lead for Rare Disease — Remote

Travere Therapeutics; Detroit (MI); Remote; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plan with employer match

Generous paid time off

Job summary

Travere Therapeutics in San Diego, with remote options, seeks a Senior Manager, Drug Safety & Pharmacovigilance to lead PV operations, ICSR management, vendor oversight, regulatory reporting, CAPAs, and safety data reconciliation across pre- and post-market activities.

Requires 6+ years in Drug Safety/Pharmacovigilance, strong medical review, ICSR processing, DSURs/PBRERs, and regulatory knowledge (FDA/ICH).

Qualifications

• Bachelor's degree in life sciences required or healthcare-related degree.
• 6+ years in Drug Safety/Pharmacovigilance experience.
• Experience with ICSR processing and regulatory reporting.

Responsibilities

• Manage day-to-day PV operations and ICSR processing.
• Vendor oversight and KPI monitoring.
• Regulatory reporting compliance and CAPA coordination.
• Safety data reconciliation and audit readiness.
• Contribution to risk management and labeling activities.

Skills

Pharmacovigilance

ICSR processing

Medical review

Vendor oversight

Regulatory compliance

DSURs/PBRERs

Education

Bachelor's degree in life sciences

Tools

ARGUS

ARISg

Job description

Travere Therapeutics in San Diego, with remote options, seeks a Senior Manager, Drug Safety & Pharmacovigilance to lead PV operations, ICSR management, vendor oversight, regulatory reporting, CAPAs, and safety data reconciliation across pre- and post-market activities.

Requires 6+ years in Drug Safety/Pharmacovigilance, strong medical review, ICSR processing, DSURs/PBRERs, and regulatory knowledge (FDA/ICH).