Praxis

Focused patient recruitment.

Associate Director, PV Scientist

DirectorDirectorFull TimeRemoteTeam 11-50Since 2002H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

$136K - $156K / year

3 yrs expEnglish

Job Description

• Serve as the U.S. facing PV leader, ensuring timely follow-up on safety actions across global teams and time zones. • Own oversight of end-to-end PV service providers, including governance meetings, KPI monitoring, TMF documentation, and continuous process improvement. • Contribute to the development and evolution of PV SOPs, safety management plans, and database migrations. • Support signal detection activities, literature review, aggregate report preparation, and safety governance meetings. • Prepare and/or QC safety narratives, regulatory safety responses, IND/NDA/MAA components, and DSMB materials. • Collaborate with Clinical Operations, Regulatory, Medical Affairs, Commercial, and Quality.

Job Requirements

  • Nurse, Nurse Practitioner, Pharmacist, or Allied Health Professional.
  • Minimum 3-5 years of experience in pharmacovigilance within the pharmaceutical/biotechnology industry.
  • At least 1 year of clinical trial experience highly desirable.
  • Experience with regulatory filings (INDs, NDAs, MAAs).
  • Strong knowledge of FDA, EMA, ICH, and GVP pharmacovigilance regulations.
  • Experience in individual case safety reporting, aggregate reporting, signal detection, risk management planning, and PV SOP development.
  • Experience implementing safety databases and signal detection tools preferred.
  • Familiarity with MedDRA and WHO-Drug coding.
  • Excellent written and verbal communication skills.

Benefits

  • 99% of the premium paid for medical, dental and vision plans.
  • Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
  • 401(k) matching dollar-for-dollar up to 6% on eligible contributions.
  • Long-term stock incentives and ESPP.
  • Discretionary quarterly bonus.
  • Extremely flexible wellness benefit.
  • Generous PTO, paid holidays and company-wide shutdowns.

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