Senior Drug Safety & Pharmacovigilance Lead - Remote

Travere Therapeutics; Denver (CO); Remote; USD 132,000 - 172,000; Full time

Job summary

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, is seeking a Senior Manager, Drug Safety & Pharmacovigilance to support PV operations and safety science across the organization.

The role involves ICSR management, medical review, regulatory reporting, and risk management activities, with opportunities to contribute to DSURs, PSURs, and safety documentation. This position is based in San Diego with a remote US work option and occasional travel.

Qualifications

• Bachelor's degree in life sciences required; 6+ years in Drug Safety/Pharmacovigilance.
• Experience with ICSR processing and regulatory reporting compliance.
• Strong analytical and communication skills; travel up to 10%.

Responsibilities

• Support PV operations and compliance, including case processing and regulatory reporting.
• Perform medical review and safety data reconciliation across trials and post-marketing.
• Contribute to aggregate safety reports (DSURs, PSURs) and risk management documentation.
• Lead safety governance activities and maintain inspection readiness.
• Collaborate with partners to ensure PV agreements and SDEAs are followed.

Skills

ICSR processing

Safety data review

Regulatory reporting compliance

Vendor oversight

Analytical skills

Communication skills

Project management

Education

Bachelor's degree in life sciences

Healthcare professional qualification preferred (RN/BSN/PharmD etc.)

Tools

ARGUS/ARISg

Job description

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, is seeking a Senior Manager, Drug Safety & Pharmacovigilance to support PV operations and safety science across the organization.

The role involves ICSR management, medical review, regulatory reporting, and risk management activities, with opportunities to contribute to DSURs, PSURs, and safety documentation. This position is based in San Diego with a remote US work option and occasional travel.