Senior Drug Safety & PV Lead (Remote)

Travere Therapeutics; Des Moines (IA); Remote; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health benefits

Stock options

Generous paid time off

Job summary

Travere Therapeutics in San Diego, remotely located globally, seeks a Senior Manager, Drug Safety & Pharmacovigilance to lead PV operations and safety science activities. You will oversee ICSR processing, regulatory reporting, vendor oversight, and CAPA programs to ensure global compliance across trials and post-marketing.

Apply your medical review expertise, data reconciliation skills, and strategic thinking to drive DSURs, PSURs, and risk management initiatives in support of patients with rare

Qualifications

• Bachelor's degree in life sciences or related field; healthcare professional degree preferred.
• 6+ years in Drug Safety/Pharmacovigilance in pharma/Biotech/CRO.
• Experience with ICSR processing and regulatory reporting compliance.
• Strong analytical and written/verbal communication skills.

Responsibilities

• Manage day-to-day PV operations internally and with PV service providers.
• Ensure global regulatory reporting timelines for expedited safety reports.
• Perform quality review of ICSRs and safety documents for regulatory compliance.
• Monitor PV vendor performance and coordinate issue resolution.
• Conduct safety data reconciliations across sources and databases.
• Support safety activities with partners, including safety plans and SDEAs.
• Lead or support CAPAs, inspections readiness, and PV SOP revisions.
• Contribute to safety sections of regulatory documents and responses.

Skills

ICSR processing

Regulatory compliance

Medical review

Data reconciliation

Vendor oversight

Project management

Communication

Travel readiness

Education

Bachelor's degree in life sciences or related field

Tools

ARGUS

ARISg

Job description

Travere Therapeutics in San Diego, remotely located globally, seeks a Senior Manager, Drug Safety & Pharmacovigilance to lead PV operations and safety science activities. You will oversee ICSR processing, regulatory reporting, vendor oversight, and CAPA programs to ensure global compliance across trials and post-marketing.

Apply your medical review expertise, data reconciliation skills, and strategic thinking to drive DSURs, PSURs, and risk management initiatives in support of patients with rare