Remote Senior Manager, Drug Safety & Pharmacovigilance

Travere Therapeutics; Providence (RI); Remoto; USD 132.000 - 172.000; Tempo pieno

Vantaggi offerti da questo lavoro

Premium health insurance

Wellness programs

Employee support programs

Retirement plans with company match

Generous paid time off

Descrizione del lavoro

Travere Therapeutics is seeking a Senior Manager, Drug Safety & Pharmacovigilance (DSPV) to oversee PV operations, supplier oversight, and regulatory reporting. The role emphasizes medical review of ICSRs and collaboration with safety scientists to ensure high-quality safety data.

You will drive risk management activities, review safety information in regulatory documents, and support inspections and CAPA initiatives.

Competenze

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

Mansioni

• Support day-to-day pharmacovigilance operations and ICSR processing.
• Perform medical review of safety data and coding checks.
• Contribute to aggregate safety reports (DSURs, PSURs, PBRERs) and risk documents.
• Ensure compliance with global regulatory requirements and SOPs.

Conoscenze

Icsr processing

Medical review

Pharmacovigilance

Regulatory knowledge

Formazione

Bachelor's degree in life sciences

Strumenti

ARGUS

ARISg

MS Excel

MS Word

Descrizione del lavoro

Travere Therapeutics is seeking a Senior Manager, Drug Safety & Pharmacovigilance (DSPV) to oversee PV operations, supplier oversight, and regulatory reporting. The role emphasizes medical review of ICSRs and collaboration with safety scientists to ensure high-quality safety data.

You will drive risk management activities, review safety information in regulatory documents, and support inspections and CAPA initiatives.