Senior Pharmacovigilance Lead – Remote

Travere Therapeutics; Salt Lake City (UT); Hybrid; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health benefits

Stock-based compensation

Generous paid time off

Job summary

Travere Therapeutics is seeking a Senior Manager for Drug Safety & Pharmacovigilance to oversee day-to-day PV operations and ensure regulatory compliance across trials and post-marketing safety activities.

The role includes medical review of ICSRs, signal detection, risk management input, and collaboration with safety science teams. Ability to manage vendors and travel 10% is required.

Qualifications

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

Responsibilities

• Manage day-to-day pharmacovigilance operations, including case processing.
• Monitor regulatory reporting timelines for expedited safety reports.
• Perform quality review of safety documentation for regulatory compliance.
• Oversee PV vendor performance and KPIs; escalate issues as needed.
• Support safety data reconciliations and data integrity activities.
• Contribute to safety sections of clinical and regulatory documents.
• Support preparation of DSURs, PADERs, PSURs/PBRERs and signal management.

Skills

ICSR processing

Medical review

Regulatory reporting

Safety data reconciliation

Vendor oversight

Safety governance

Education

Bachelor's degree in life sciences

Tools

ARGUS/ARISg

MedDRA

WHO Drug coding

Job description

Travere Therapeutics is seeking a Senior Manager for Drug Safety & Pharmacovigilance to oversee day-to-day PV operations and ensure regulatory compliance across trials and post-marketing safety activities.

The role includes medical review of ICSRs, signal detection, risk management input, and collaboration with safety science teams. Ability to manage vendors and travel 10% is required.