Senior Drug Safety & Pharmacovigilance Leader - Remote

Travere Therapeutics; New York (NY); Remote; USD 132,000 - 172,000; Full time

Job summary

Travere Therapeutics in San Diego, with a remote-friendly setup, seeks a Senior Manager, Drug Safety & Pharmacovigilance to lead day-to-day PV operations and medical review, ensuring regulatory compliance across DSPV and Safety Science.

You will oversee ICSR processing, vendor oversight, and preparation of DSURs/PSURs, while contributing to risk management, labeling acts, and safety document reviews in a collaborative, fast-paced environment.

Qualifications

• Bachelor's degree in life sciences or related field; healthcare degree preferred.
• 6+ years of Drug Safety/Pharmacovigilance experience in pharma/biotech/CRO.
• Experience with ICSR processing, medical review, and regulatory reporting.

Responsibilities

• Perform medical review of ICSRs from trials and post-marketing sources.
• Contribute to planning, authoring and quality control of DSURs, PADERs, PSURs, and safety analyses.
• Review safety information in clinical study documents and regulatory submissions.
• Support safety signal management and risk management documentation.
• Oversee safety data reconciliation with clinical databases and vendor data.
• Lead or support audits and inspections readiness in pharmacovigilance.

Skills

ICSR processing

Pharmacovigilance

Vendor oversight

Regulatory reporting

Safety data reconciliation

Medical review

Signal detection

DSURs/PADERs/PSURs

Safety documentation review

Education

Bachelor's degree in life sciences

Tools

ARGUS

ARISg

Job description

Travere Therapeutics in San Diego, with a remote-friendly setup, seeks a Senior Manager, Drug Safety & Pharmacovigilance to lead day-to-day PV operations and medical review, ensuring regulatory compliance across DSPV and Safety Science.

You will oversee ICSR processing, vendor oversight, and preparation of DSURs/PSURs, while contributing to risk management, labeling acts, and safety document reviews in a collaborative, fast-paced environment.