Senior Manager, Drug Safety & Pharmacovigilance — Remote

Travere Therapeutics; Boston (MA); Hybrid; USD 132,000 - 172,000; Full time

Job summary

Travere Therapeutics in San Diego, USA, seeks a Senior Manager for Drug Safety & Pharmacovigilance to support day-to-day pharmacovigilance and safety science activities. You will oversee ICSR processing, vendor oversight, and regulatory reporting across DSPV Operations and Safety Science.

You will perform medical reviews of ICSRs, contribute to aggregate safety reports, and review safety information in clinical/regulatory documents.

Qualifications

• Bachelor's degree in life sciences or related field required.
• 6+ years of experience in Drug Safety/Pharmacovigilance within the pharmaceutical, biotechnology, or CRO industry.
• Experience with ICSR processing and medical review, including causality, coding, and regulatory reporting compliance.

Responsibilities

• Support day-to-day pharmacovigilance operations, including ICSR processing and vendor oversight.
• Monitor regulatory reporting timelines for expedited safety reports.
• Lead safety data reconciliations and CAPA implementation.
• Contribute to safety sections of clinical and regulatory documents.
• Support preparation of DSURs and PSURs, and risk management plans.

Skills

ICSR processing

Medical review

Regulatory reporting

PV vendor oversight

Signal detection

Education

Bachelor's degree in life sciences or related field

Healthcare professional degree (RN/PharmD/PA/NP)

Tools

ARGUS/ARISg safety databases

MedDRA/WHO Drug coding

Job description

Travere Therapeutics in San Diego, USA, seeks a Senior Manager for Drug Safety & Pharmacovigilance to support day-to-day pharmacovigilance and safety science activities. You will oversee ICSR processing, vendor oversight, and regulatory reporting across DSPV Operations and Safety Science.

You will perform medical reviews of ICSRs, contribute to aggregate safety reports, and review safety information in clinical/regulatory documents.