Senior Manager, Drug Safety & Pharmacovigilance - Remote

Travere Therapeutics; Manchester (NH); Presencial; USD 132.000 - 172.000; Jornada completa

Descripción de la vacante

Travere Therapeutics seeks a Senior Manager, Drug Safety & Pharmacovigilance to lead PV operations, medical review of ICSRs, and regulatory reporting across clinical and post-marketing activities.

The role covers safety data reconciliation, signal detection, DSUR/PADER review, and collaboration with partners to ensure compliance. Requires 6+ years in PV and travel up to 10% domestically/internationally; onsite in San Diego.

Formación

• Bachelor's degree in life sciences or related field; healthcare qualification preferred.
• 6+ years in Drug Safety/Pharmacovigilance across development and post-marketing.
• Experience with ICSR processing and regulatory reporting compliance.

Responsabilidades

• Manage day-to-day PV operations with internal teams and service providers.
• Oversee safety data submissions, timelines and quality reviews.
• Lead or support safety data reconciliations and vendor oversight.
• Contribute to aggregate reports (DSURs, PADERs, PSURs) and regulatory documents.
• Support signal management, risk management plans, and REMS where applicable.
• Collaborate with safety governance and cross-functional teams.

Conocimientos

ICSR processing

Medical review

Pharmacovigilance

Vendor oversight

Regulatory reporting

Safety data reconciliation

DSURs/PADERs review

Signal detection

Cross-functional collaboration

Educación

Bachelor's degree in life sciences

Herramientas

ARGUS

ARISg

Descripción del empleo

Travere Therapeutics seeks a Senior Manager, Drug Safety & Pharmacovigilance to lead PV operations, medical review of ICSRs, and regulatory reporting across clinical and post-marketing activities.

The role covers safety data reconciliation, signal detection, DSUR/PADER review, and collaboration with partners to ensure compliance. Requires 6+ years in PV and travel up to 10% domestically/internationally; onsite in San Diego.