Senior Drug Safety & Pharmacovigilance Lead (Remote)

Travere Therapeutics; Columbia (SC); Hybrid; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health benefits

401(k) with employer match

Wellness programs

Job summary

Travere Therapeutics in San Diego, with remote-friendly setup, seeks a Senior Manager for Drug Safety & Pharmacovigilance to lead day-to-day PV operations and medical reviews. You will manage ICSR processing, vendor oversight, regulatory reporting, and CAPA initiatives to ensure safety data integrity across the portfolio.

The role requires 6+ years in PV, strong regulatory knowledge, and the ability to collaborate across safety science and clinical teams in a fast-paced environment.

Qualifications

• Bachelor's degree in life sciences or related field required; healthcare background preferred.
• 6+ years in Drug Safety/Pharmacovigilance with clinical and post-marketing experience.
• Experience with ICSR processing, regulatory reporting, and case management.

Responsibilities

• Manage day-to-day PV operations internally and with vendors.
• Ensure compliance with regulatory reporting timelines for safety reports.
• Perform ICSR quality reviews and data reconciliations to ensure accuracy.
• Oversee PV deviations, CAPA development, and audits/inspections readiness.
• Lead medical review of ICSRs, clinical safety data review, and signal detection.

Skills

ICSR processing

Regulatory reporting

PV oversight

Safety data reconciliation

Risk management

Education

Bachelor's in life sciences

Tools

ARGUS

MedDRA

Job description

Travere Therapeutics in San Diego, with remote-friendly setup, seeks a Senior Manager for Drug Safety & Pharmacovigilance to lead day-to-day PV operations and medical reviews. You will manage ICSR processing, vendor oversight, regulatory reporting, and CAPA initiatives to ensure safety data integrity across the portfolio.

The role requires 6+ years in PV, strong regulatory knowledge, and the ability to collaborate across safety science and clinical teams in a fast-paced environment.