Senior DSPV Lead for Rare-Disease Drug Safety

Travere Therapeutics; Washington (District of Columbia); On-site; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Generous paid time off

Job summary

Qualifications

• 6+ years of experience in Drug Safety/Pharmacovigilance within pharma/biotech/CRO
• Experience with ICSR processing and regulatory reporting
• Knowledge of safety database systems and coding conventions (MedDRA, WHO)

Responsibilities

• Manage day-to-day pharmacovigilance operations
• Ensure regulatory reporting timelines for expedited safety reports
• Perform safety data reconciliations and review safety documentation
• Lead medical review of ICSRs and aggregate safety reports (DSURs, PADERs, PSURs)
• Review safety information in regulatory documents and SOPs

Skills

Pharmacovigilance

Attention to detail

Cross-functional collaboration

Data analysis

Education

Bachelor's degree in life sciences

Healthcare professional degree preferred

Tools

ARGUS

ARISg

Job description