Senior Pv Scientist

Praxis Precision Medicines

Remote
Remote
Pharmacovigilance data analysis
Safety surveillance
Regulatory compliance
The Senior PV Scientist supports the medical oversight, analysis, coding, interpretation, and reporting of pharmacovigilance data, contributing to high-quality safety surveillance and regulatory compliance

Job Summary

  • The Senior PV Scientist supports the medical oversight, analysis, coding, interpretation, and reporting of pharmacovigilance data, contributing to high-quality safety surveillance and regulatory compliance.
  • This role plays a critical part in strengthening the U.S.-based pharmacovigilance footprint, enhancing vendor oversight, and ensuring inspection readiness as the company advances its pipeline.
  • Primary responsibilities include serving as the U.S. facing PV leader, owning oversight of PV service providers, and contributing to the development of PV SOPs and safety management plans.

Matching Summary

The Senior PV Scientist supports the medical oversight, analysis, coding, interpretation, and reporting of pharmacovigilance data, contributing to high-quality safety surveillance and regulatory compliance.

Skills & Requirements

Must-have

  • pharmacovigilance data analysis
  • safety surveillance
  • regulatory compliance
  • vendor oversight
  • signal detection
  • benefit-risk evaluation

Nice-to-have

  • ownership mindset
  • operational rigor
  • scientific judgment
  • proactive problem solving

Key Requirements

  • 3-5 years pharmacovigilance experience
  • 1 year clinical trial experience
  • Experience with regulatory filings
  • Knowledge of FDA, EMA, ICH, GVP regulations
  • Experience with ICSRs and aggregate reporting
  • Familiarity with MedDRA and WHO-Drug coding

Work Rights

Not specified

Tailored Resume

Cover Letter