Senior Safety & Pharmacovigilance Leader - Remote

Travere Therapeutics; Minneapolis (MN); Hybride; USD 132 000 - 172 000; Plein temps

Résumé du poste

Travere Therapeutics is seeking a Senior Manager, Drug Safety & Pharmacovigilance to support pre- and post-marketing safety activities in a global setting. The role covers ICSR management, medical review, signal detection and DSUR/PADER/PSUR contributions.

The position requires 6+ years in PV, familiarity with safety databases (ARGUS/ARISg), and strong regulatory/compliance knowledge. Travel up to 10% domestically/internationally; on-site in San Diego with remote flexibility.

Qualifications

• Minimum 6+ years in Drug Safety/Pharmacovigilance in pharma/biotech/CRO.
• Experience with ICSR processing, medical review, coding and signal detection.
• Ability to prepare DSURs, PSURs and regulatory responses.

Responsabilités

• Support PV operations, including case processing and vendor oversight.
• Ensure regulatory reporting compliance and data reconciliation.
• Lead or support risk management, CAPAs and audits.
• Review safety information in clinical/regulatory documents.
• Contribute to safety reports and safety sections of documents.

Connaissances

Analytical thinking

Communication skills

Regulatory compliance

Vendor oversight

Safety surveillance

DSURs/PBRERs knowledge

ICSR medical review

MedDRA/WHO coding familiarity

Safety database systems

Attention to detail

MS Word/Excel/PowerPoint

Formation

Bachelor's degree in life sciences or related field

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

Outils

ARGUS/ARISg

MS Office Suite

Description du poste

Travere Therapeutics is seeking a Senior Manager, Drug Safety & Pharmacovigilance to support pre- and post-marketing safety activities in a global setting. The role covers ICSR management, medical review, signal detection and DSUR/PADER/PSUR contributions.

The position requires 6+ years in PV, familiarity with safety databases (ARGUS/ARISg), and strong regulatory/compliance knowledge. Travel up to 10% domestically/internationally; on-site in San Diego with remote flexibility.